As a licensed practitioner, you are responsible for properly prescribing, administering and dispensing controlled substances. How you handle these drugs is critical to ensuring patients’ health and safeguarding society against their (illegal) diversion. Whether you are administering a sedative to relax a patient before a minor surgery (e.g., LASIK) or anesthetizing a patient before a major surgery (e.g., cataract surgery), it is your duty to know the laws pertaining to the handling of controlled substances.

To aid you, this article focuses on regulations specific to dispensing and storing controlled substances in ophthalmology offices and ASCs based on the Drug Enforcement Administration (DEA) Practitioner’s Manual.

PRACTITIONER GUIDELINES

Under the Controlled Substances Act (CSA), practitioner is defined as “a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital or other person licensed, registered or otherwise permitted, by the United States or the jurisdiction in which the practitioner practices or performs research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research. Every person or entity that handles controlled substances must be registered with DEA or be exempt by regulation from registration.”¹

Each registrant must maintain the certificate of registration at the indicated location in a readily retrievable manner and make it available for official inspection.² If a practitioner is registered at one location but also practices at other locations, he or she is not required to register separately for any other location at which controlled substances are only prescribed.¹ However, if the practitioner maintains supplies of, administers or directly dispenses controlled substances at the separate location, he or she must obtain a separate DEA registration for that location. The only exception to this rule is if the secondary location is located within the same state in which the practitioner maintains his or her registration. Since a DEA registration is based on a state license, it cannot authorize controlled substance dispensing outside that state. Hence, the separate registration exception applies only to locations within the same state in which practitioners have their DEA registrations.

DRUG SCHEDULES

To properly handle controlled substances within a practice or ASC, practitioners must know how the drugs they use are categorized by the DEA. The CSA divides controlled substances into five schedules. Each drug’s designation is based on:

1. Whether it has a currently accepted medical use in treatment in the United States
2. Its relative abuse potential
3. The likelihood of causing dependence when abused

Current scientific evidence of its pharmacological effects, if known, is also considered.³

A complete list of the designated schedules and their pertaining drugs — which is published and updated annually — can be found in DEA regulations, Title 21 of the Code of Federal Regulations, Sections 1308.11 through 1308.15.¹ As the list is extensive, I’ve summarized the schedules below and included the drugs most commonly used in ophthalmology practices and ASCs where applicable. The following information, which summarizes key point from the DEA’s Practitioner’s Manual, is intended to provide a general reference. It is not a comprehensive list.

• Schedule I. Substances in this schedule have no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision and a high potential for abuse. Examples of Schedule I drugs include, but are not limited to: heroin, peyote, marijuana (cannabis) and methaqualone.
• Schedule II. Substances in this schedule have a high potential for abuse, which may lead to severe psychological or physical dependence. These drugs either have a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions.⁴ Examples of Schedule II narcotics include morphine, codeine, methadone (Dolophine) and oxycodone (OxyContin).¹
• Schedule III. Substances in this schedule have less potential for abuse than substances in Schedule I or II. These drugs have a currently accepted medical use in treatment in the United States; the same applies to Schedule IV and Schedule V substances.⁴ Examples of Schedule III narcotics include products containing less than 15 mg of hydrocodone per dosage unit (Vicodin) and products containing no more than 90 mg of codeine per dosage (Tylenol with Codeine).¹
• Schedule IV. Substances in this schedule have a lower potential for abuse relative to substances in Schedule III. Examples of a Schedule IV substances include alprazolam (Xanax) and diazepam (Valium).
• Schedule V. Substances in this schedule have a lower potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics and stimulant drugs. These are generally used for antitussive, antidiarrheal and analgesic purposes. Examples include cough preparations containing no more than 200 mg of codeine per 100 ml or per 100 g (Robitussin AC, Phenergan with Codeine).

SECURITY REQUIREMENTS

Title 21, CFR Section 1301.71(a) requires that all DEA certified practitioners provide effective controls and procedures to guard against theft and diversion of controlled substances.⁵ I have described them below:

• Physical controls. As a practitioner, it is unacceptable to keep even one bottle of a controlled substance in an unsecured location. You are required to store stocks of Schedule II through V controlled substances in a securely locked, substantially secure cabinet. Additionally, other physical safeguards are used to determine the adequacy of a practitioner’s security controls, including:
  1. The location of the premises and the relationship such location bears on security needs
  2. The type of building and office construction
  3. The type and quantity of controlled substances stored on the premises
  4. The type of storage medium (safe, vault or steel cabinet)
  5. The control of public access to the facility
  6. The adequacy of registrant’s monitoring system (alarms and detection systems)
  7. The availability of local police protection
• Employee protections. DEA registered practitioners are responsible for ensuring controlled substances are distributed only to legitimate patients or other registrants authorized to receive them.⁴ To ensure that, registrants should not employ anyone as an agent or employee with access to controlled substances who meets the follow criteria:
  1. Has been convicted of a felony offense related to controlled substances,
  2. Has been denied a DEA registration
  3. Has had a DEA registration revoked
  4. Has surrendered a DEA registration for cause⁵

Despite controls, should your practice or ASC uncover any thefts or significant losses of controlled substances, practitioners must notify the DEA upon discovery and complete DEA Form 106 regarding the incident.

• Safeguards for prescribers. In addition to the required security controls, practitioners can use additional measures to ensure security. These include:
  1. Keep all prescription blanks in a safe place where they cannot be stolen; minimize the number of prescription pads in use
  2. Write out the actual amount prescribed, in addition to giving a number, to discourage alterations of the prescription order
  3. Use prescription blanks only for writing a prescription order and not for notes
  4. Never sign prescription blanks in advance
  5. Assist the pharmacist when verifying information about a prescription order over the phone. A corresponding responsibility rests with the pharmacist — who dispenses the prescription order — to ensure the accuracy of the prescription
  6. Contact the nearest DEA field office to obtain or furnish information regarding suspicious prescription activities
  7. Use tamper-resistant prescription pads

RECORDKEEPING REQUIREMENTS

Each practitioner (i.e., practice or ASC) must maintain inventories and records of controlled substances listed in Schedules I and II separately from all other records.⁶ Likewise, inventories and records of controlled substances in Schedules III, IV and V must be maintained separately or in such a form that they are readily retrievable from ordinary business records of the practitioner. For drugs in Schedules III, IV and V, the supplier and the purchaser (practice/ASC) must still maintain records of all transactions involving these controlled substances, and those records must contain specific information required by DEA regulation.⁴ All records related to controlled substances must be maintained and be available for inspection for a minimum of two years.⁶

While a registered practitioner is required to keep records of controlled substances that are dispensed to the patient in the lawful course of professional practice, he or she is not required to keep records of controlled substances that are prescribed or administered, unless:

1. Controlled substances are prescribed or administered in the course of maintenance or detoxification treatment of an individual
2. The practitioner regularly engages in the dispensing or administering of controlled substances and charges patients — either separately or together with charges for other professional services — for the dispensed or administered substances.

INVENTORY TRACKING

The Practitioner’s Manual designates specific inventory requirements.⁶ Regardless of how small or large the quantity of controlled substances on hand at your practice or ASC, the facility must maintain a complete and accurate record of the drugs, along with the date that the inventory was conducted.

It is advisable that two licensed team members conduct an inventory together and that accurate documentation of the inventory is recorded. This record must be in written, typewritten or printed form and be maintained at the registered location for at least two years from the date that the inventory was conducted.

Whenever controlled substances are accessed after an initial inventory is taken, designated practice or ASC staff shall take a new inventory of the substances on hand at both the beginning and end of the day or shift.⁶

Each inventory must contain, but is not limited to, the following information:

1. Whether the inventory was taken at the beginning or close of business
2. Names of controlled substances on hand
3. Each finished form (i.e., tablet, syringe, vial) of the substance (e.g., 100 mg tablet)
4. The number of dosage units of each finished form in the commercial container (e.g., 100 tablet bottle)
5. The number of commercial containers of each finished form (e.g., four 100 tablet bottles)
6. Disposition of the controlled substances

STAY INFORMED

While most ophthalmology practices or ASCs have limited controlled substances in their facility, the CSA is applicable to the daily operations of the facility, regardless of size or volume.

The CSA regulations and laws regarding the prescribing, administering and dispensing of controlled substances are nuanced and complex, but they are necessary to ensure patient and public health. OM

Author’s note: This article is intended to summarize the basic regulations regarding controlled substances as they relate to medical practices, but it is not comprehensive. For further interpretation and guidance on DEA policies, please contact ODLP@usdoj.gov or mail your questions to: DEA Diversion Control Division, Attn: Liaison and Policy Section, 8701 Morrissette Drive, Springfield VA 22152.

REFERENCES

1. U.S. Department of Justice, Drug Enforcement Administration, Diversion Control Division. Practitioner’s Manual – Section II. https://www.deadiversion.usdoj.gov/pubs/manuals/pract/section2.htm . Accessed August 28, 2019.
2. U.S. Department of Justice, Drug Enforcement Administration, Diversion Control Division. Title 21 Code of Federal Regulations. Part 1301. https://www.deadiversion.usdoj.gov/21cfr/cfr/1301/1301_35.htm . Accessed August 28, 2019.
3. United States Drug Enforcement Administration. The Controlled Substances Act. https://www.dea.gov/controlled-substances-act . Accessed August 28, 2019.
4. U.S. Department of Justice Drug Enforcement Administration. Drugs of Abuse. A DEA resource guide 2017 edition. https://www.dea.gov/sites/default/files/drug_of_abuse.pdf . Accessed August 28, 2019.
5. U.S. Department of Justice, Drug Enforcement Administration, Diversion Control Division. Practitioner’s Manual - SECTION III. https://www.deadiversion.usdoj.gov/pubs/manuals/pract/section3.htm . Accessed August 28, 2019.
6. U.S. Department of Justice, Drug Enforcement Administration, Diversion Control Division. Practitioner’s Manual – SECTION IV. https://www.deadiversion.usdoj.gov/pubs/manuals/pract/section4.htm . Accessed August 28, 2019.

About the Author

C. Jolynn Cook, RN, COE, CASC, is a senior consultant with BSM Consulting. She is a registered nurse with significant experience in ASC and ophthalmic practice management. Email her at jdcook@bsmconsulting.com or call 814-715-7584.