By: Christopher M. Dembny R.Ph.

One of the first places that all the regulatory and accreditation agencies look is controlled substance documentation.  While avoidance of drug diversion is of the utmost importance to all, many people get in trouble over their record keeping even when no diversion problem exists.  The following is a checklist of things you should make sure are in place so that you don’t get in trouble over paperwork.  You need to make sure you have them AND know where they are.  It is not a good feeling to know that you have been doing things correctly and not be able to find them when requested by a Board of Pharmacy or DEA agent.  Please make sure you have these items documented correctly and available if asked to produce them.

Christopher M. Dembny R.Ph.

1. Initial and annual controlled substance inventories.  All facilities licensed by the Board of Pharmacy and the DEA are required to do an initial inventory and an annual controlled substance inventory.  This is required to have the notarized signature of the Pharmacist-In-Charge (PIC) on it.  It must be done annually within three days of the annual inventory date.  A board of Pharmacy Compliance Officer will ALWAYS request this.

2. Controlled substance invoices must be maintained correctly.  Schedule II invoices must be maintained in a file separate from all other items.  I recommend always attaching the corresponding DEA 222 form to the invoice(s) for these drugs.  Be sure to complete the number of packages received and the date received on the DEA 222 form for drugs received.  The pharmacist is required to sign all CII invoices after the drug has been received.  The statute of limitations for all controlled substance documentation is 2 years, so these must be maintained on site (unless otherwise approved by the DEA) for 2 years.

3. Invoices for drugs in schedules CIII-V are required to be maintained separately from all other invoices.  These must all also be signed by the pharmacist after receipt.  I usually keep this file right next to the file with the CII invoices.

4. A perpetual inventory must be maintained for all drugs in schedule II.  Everyone that I consult for keeps a perpetual inventory for all controlled substances, but it is required for CII’s.  This means that your perpetual inventory log MUST match what is actually in your narcotic storage cabinet.  It’s much easier to get it right than explain why it is not.

5. CII records must be maintained separately from CIII-V records.  To do this, you must at least group all of your CII’s together on your perpetual inventory document.  I’ve never had an agent tell me this wasn’t enough separation, but SEPARATELY isn’t defined in the DEA rules or the pharmacy rules.

6. Every time a controlled substance is administered to a patient, nine items are required to be documented on the controlled substance administration record.  These are:

• • • Date
    • Time of administration
    • Patient’s name
    • Drug and dosage form administered
    • Amount administered
    • Amount wasted (if any)
    • SIGNATURE of the person administering the controlled substance
    • SIGNATURE of the person witnessing waste (if any)
    • NAME of the ordering practitioner.

*The items required in this section must be maintained separately from patient charts.  Don’t plan on telling the DEA that they can look through all of your charts if they want details on your controlled substances. Most places have a specific narcotic log in which they keep a perpetual inventory and document administrations.

7. You must correctly document any transfers of controlled substance between registrants (into or out of your facility).  There is no such thing as “loaning” a sister facility a box of morphine.  Any time a controlled substance is moved from one registrant to another, proper documentation must be done.  This is in the form of an invoice and a DEA 222 form (if the drug moved is a CII).

8. You may not destroy expired controlled substances.  That must be done by a reverse distributor company that is licensed by the DEA to do so.

9. Keep a copy of your current pharmacy, DPS, and DEA license posted somewhere near your drugs.  If an agency is coming to look at your controlled substances, they will also want to see those licenses.

10. If someone other than the person on the DEA license will be signing DEA 222’s, keep a valid power of attorney document for that person on file with your other paperwork.  DEA 222’s may be signed by the person authorized to sign the DEA license application and anyone to whom they assign power of attorney.

11. This item is not a legal requirement, but is a great tool to prevent diversion.  Most wholesalers will provide a monthly statement of all the controlled substances that have been shipped to your facility.  This is a very valuable tool to prevent diversion.  If you can get this document and compare it to the signed invoices in your invoice file, you can validate that all controlled substances shipped to your facility have been added to the perpetual inventory (and not been taken home for party time by an employee).

This is not a comprehensive list of all things that can get you in trouble, but if you have these items in place, you’ve got 95% of what they might ask for and will have already shown such a knowledge of the requirements that it would be rare for an agency to dig any farther.

This article was submitted by Christopher M. Dembny R.Ph.  He is a member of TAFEC and currently consults for over 40 free-standing emergency rooms.  He can be reached for questions at [email protected]