Article

Compliance

Managing controlled substances

Eight tips to stay in compliance with DEA requirements.

Most ophthalmic professionals are not experts in Drug Enforcement Administration (DEA) law; however, they need to be familiar with DEA requirements for storing and dispensing controlled substances when a physician uses them in the office setting.

To purchase controlled substances, providers must register with the DEA and obtain a DEA license/permit. The license must be renewed annually and has a fee.

Practices that perform LASIK or vision-correction procedures often offer Valium to the patient to manage anxiety associated with the procedure. Other medications listed in this article may be found/used/associated more commonly with minor procedures or in an ambulatory surgery center.

Ophthalmic staff need to keep the following tips in mind when managing controlled substances.

Document medication orders in the medical record.

This should happen whenever a physician orders the medication and include the reason for the medication.

Assign a “keeper of the keys.”

When this person (preferably a licensed nurse or the physician) is away, that person should appoint a licensed staff member to be responsible for the office’s controlled substances.

Implement a tracking system.

Using a punch card (numbering the tablets) is a simple, helpful way to track controlled substances. If the practice does not have a management procedure in place, involve a local or consulting pharmacist to help implement a management procedure. Pharmacists can provide input and answer questions and will be familiar with any local or state requirements.

Also, a sign-out sheet kept with the controlled medication in or near the storage cabinet should include the count of tablets on hand. The sheet requires a staff signature (preferably the dispensing nurse’s), patient information, date, time that the drug is administered, and the reason for the medication.

Double-check inventory.

Two (licensed, when possible) staff should count the tablets together before and after the LASIK day begins and ends.

Report any disparity in the drug count to the practice manager and investigate it immediately.

Use proper storage.

A double-locked system (a locked cabinet inside another locked cabinet) that is not portable is required.

Keep records.

A tracking and monitoring log/book with records must be on file for two years.

DEA certification.

This must be on file with the practice for a physician or provider who prescribes or administers controlled substances. Consider keeping the DEA certificate as part of the provider’s credentialing file.

Consult a pharmacist.

If the office has only one medication it obtains, such as Valium tablets for refractive patients, the pharmacy where it is obtained is a great resource to assist with developing a policy/procedure and reviewing the regulations for storing and dispensing controlled substances with the designated (license preferred) staff.

Conclusion

Managing controlled substances in a practice setting requires that leadership understand and follow FDA rules and regulations. Taking the time to establish appropriate drug-related protocols and processes ensures compliance and keeps everyone safe. OP

Always consult legal counsel for approval of practice policies and procedures for any regulated information.