Controlled Substance Transfers: Ensuring Internal Management from Site to Site

Whenever medications are purchased from any entity, a process must be followed that allows for tracing the medications with ease. When it comes to controlled substances, every individual vial, syringe, or bag must be easily tracked. When pharmacies order medication from traditional distributors, the process is rather automated and straight forward. However, when alternative or home-grown methods of acquiring controlled substances are utilized, additional review of the ordering process, completion of forms, transportation, and receipt of the medication must be put under the microscope to ensure the Code of Federal Regulations (CFR) Title 21 and state regulations are followed.

When transferring controlled substances, we should be reminded that this is taking place between 2 separate registrants. This very principal is the central viewpoint for how transfer requirements are outlined in the CFR and state regulations. Muddied are the waters of inter-facility transport when using terms like “medical office building clinic,” “hospital-based surgery center,” or “Joint Commission surveyable site.” Although all of these terms speak to a relationship of a specialty or ambulatory site that is related to a traditional acute care setting, this relationship does not apply when speaking from the controlled substance perspective. These sites most often have their own state-controlled substance permit and Drug Enforcement Administration (DEA) license. When this is the case, all controlled substance transfer formalities are required. To review those formalities in more detail, site-to-site transfer is divided into 2 categories:¹

• Inter-facility transfers from one health care-owned site to another (“In-Network Transfer”)
• Transfer from one health care-owned site to an outside health system or practice site (“Out-of-Network Transfer”)

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Regardless of the type, internal transfer forms (ITF) must be used to capture medication name/strength/quantity, DEA number, physical address of the sending and receiving site, storage conditions, chain of custody, and signature/date fields.¹ Forms should come pre-populated with the DEA number and address for all hospital sites within the system along with a blank field that can be completed when sending to lesser-known sites. If transporting a patient-specific medication, a unique disposition form should be used in addition to the ITFs.¹

Any time a schedule 2 medication is being transferred, a single-sheet DEA-222 must be executed in real time. This must be originated by the requesting/purchasing site by an authorized individual with Power of Attorney (POA) to sign a DEA-222. Prior to sending to the supplier, the purchasing site must make a copy of the DEA-222. The supplier will receive the form and then complete the purchaser section, and it is at this point the supplier must ensure their DEA number is recorded on the form. The supplier will then retain the original DEA-222, make a copy of the completed form, and ensure submission to DEA.Orderforms@usdoj.gov by the close of the month during which the medication was ordered. The supplier cannot send the medication to any other address that is indicated on the DEA-222.²

Maintaining a central source of distribution from the central pharmacy vault is a key component of a drug diversion program when reviewing the movement of medications within a site. This concept should apply to inter-facility transfers as well. Controlled substances should be pulled from a central pharmacy automated dispensing cabinet (ADC) vault when supplying to another site. Medications should not be pulled from manual storage or traditional ADCs located on nursing units. In the same interest, these medications should be loaded into the receiving site’s vault (if transferring to another acute care site). When this takes place, electronic review of send and receipt allows for easy auditing immediately post-transfer, but also when performing regularly scheduled pharmacy-controlled substance audits.

The day following the transfer of medication, best practice when performing an in-network transfer is that the sending site reviews the medication sent to ensure it was received into the pharmacy (or central storage) at the receiving site. This review is paramount to ensure diversion is not taking place by someone requesting stock. This method of diversion can sometimes go unnoticed as pharmacy leaders or traditional audits often focus on in-house dispenses.

Unfortunately, not all transfers can be clean from one central pharmacy to another. At times, patient-specific medications must be transferred after hours from one 24-hour operating pharmacy to a site without one. This scenario brings about additional risks that the medication is being received by non-pharmacy personnel who have the opportunity to divert the medication. In a situation in which the receiving health care professional does not have intentions to divert the medication, errors in the receiving, documentation, and filing of paperwork can pose issues with record-keeping compliance.

The medication should be transported in a secure container by an approved courier process. Consideration should be made to utilize serial-numbered tags that allow for tracking and identification of tampering. Prior to sending a schedule 2 medication, the DEA-222 must be executed in real time. In order to achieve this, implement an on-call process that ensures a pharmacy leader is contacted when such transfer is taking place to ensure the transfer is appropriate and team members at each site have POA for executing DEA-222s. ITFs, disposition forms (when transferring patient-specific medications), and ADC automatically-generated invoices should be paired together and placed with the medication in a secured medication receptacle at time of transfer. The sending facility should ensure a copy of the ITF is made and either kept onsite or sent to a central purchasing facility if charge capture is handled centrally for the system.

Because the above outlines a rather tedious process that is occurring outside regular pharmacy hours, restrictions should be in place for when it can take place. Restrictions that should be considered include, but are not limited to, urgency of medication for patient, time the pharmacy opens at the requesting site compared to time of request, and number of doses to be sent.

Another lesser discussed area of transfer is that of reverse distribution. When controlled substances are surrendered to a reverse distributor, this is in effect a transfer of medications. Medications should be surrendered from a central pharmacy ADC vault and the central pharmacy ADC vault should be configured to automatically print reports to show the medications being surrendered to the reverse distributor. The report will allow for direct reconciliation of an individual medication and quantity to the inventory report provided by the reverse distributor. At this time, it is the responsibility of the reverse distributor to generate the DEA-222 (if surrendering schedule 2 medications) as they are the requesting entity. The surrendering site must complete the supplier section (Section 3) of the DEA-222 and ensure that the ship date is completed. A copy of the completed form must be sent to DEA by the supplier.² The original DEA-222, the reverse distributor inventory report, and the surrendered medications report from the central pharmacy ADC vault must be reviewed together. At this time, all quantities should be reconciled to ensure no discrepancies are present. This process is captured by having all reports signed and dated by the surrendering team member and the reverse distributor representative. Lastly, to validate the process is completed, sites should access the portal of their reverse distributor to view finalized transaction reports of those medications surrendered.

Annual review of transfers should take place to ensure that each site has not exceeded the 5% rule for the calendar year.³ A Root Cause Analysis (RCA) should be performed to determine the “why” behind the transfer. Are transfers taking place due to medication shortages or for convenience? Did it involve batched sterile or non-sterile products? Are formulary alternatives in place? Was this transfer urgent or could it have waited until product was received by a distributor? Once the RCA is completed, an action plan should be implemented to ensure the quantity of transfers will decrease below the threshold. If a receiving site is identified as making up the majority of transfers, the system should consider obtaining medications from a traditional distributor.

Controlled substance transfers are occurring at a higher rate as health systems create their own ecosystems to combat medication shortages. Increased scrutiny by the DEA and state regulators is being felt by health care systems across the nation and review of records by regulators are becoming more tedious during routine audits. The health care system’s ability to retrieve and reconcile these records in a timely manner is paramount to ensure concerns do not arise which could lead to a more in-depth investigation. Regular internal audits of all transfer records should take place to ensure a constant state of readiness. Ensure all forms are being used, but also ensure they are completed in their entirety, as this is a common finding. Develop a checklist that outlines what should make up your controlled substance transfer packet.Ensure all forms are dated, signed, quantities notated, and DEA number and address of sending and receiving location are accurate. Then check and double check again.

About the Author

Bethanie Gamble, PharmD, is Diversion Coordinator in the Department of Pharmacy at Prisma Health.

References

1. 21 C.F.R §1304.22

2. 21 C.F.R §1305.13

3. 21 C.F.R §1307.11