President Richard Nixon signed into law the Federal Comprehensive Drug Abuse Prevention and Control Act, more commonly known as the Controlled Substances Act (CSA), in 1970.¹ Although the Act contains three separate Titles, the main section of interest to healthcare providers is Title II, which addresses issues related to the registration and distribution of controlled substances.² The overarching goal of the Act is to improve the manufacturing, importation and exportation, distribution, and dispensing of controlled substances. To achieve this goal, manufacturers, distributors, prescribers, and dispensers of controlled substances must be registered with the Drug Enforcement Administration (DEA), the agency charged with enforcement on the federal level.³˒⁴ DEA registration essentially forms a “closed system” for controlled substances distribution, allowing for the tracing of products from initial manufacture to final dispensing. This primer highlights important aspects of the CSA for providers—including those in primary care settings—regarding scheduling, registration, and appropriate prescribing.
Schedules
Under the CSA, controlled substances, many of which have analgesic effects, are categorized into five schedules (see Table I).³˒⁴ Schedule I medications have the highest abuse potential while medications in Schedule V have a low abuse potential. Of note, many states have passed laws allowing for medical or recreational use of marijuana. State laws such as these do not alter the fact that marijuana remains a Schedule I medication under federal law (more on prescribing marijuana as a controlled substance).²
Medications may be removed or added to a Schedule or switched from one Schedule to another. For example, the DEA switched hydrocodone combination products, such as Vicodin, from Schedule III to Schedule II in 2014 due to health concerns and safety risks related to abuse and diversion.⁵ Emergency or temporary scheduling of a substance that is not currently controlled may also occur in order to avoid imminent harm to the public.
Beyond the five schedules, the CSA also contains information on “Scheduled Listed Chemical Products” or SLCPs. These are products that contain ephedrine, pseudoephedrine, or phenylpropanolamine marketed or distributed legally in the United States as nonprescription drugs. SLCPs have been used inappropriately to compound illegal substances such as methamphetamine (ie, crystal meth).
Provider Registration
As noted, every healthcare provider (HCP) that handles controlled substances must register with the DEA unless exempted by regulation, such as prescribers in the branches of the military.³˒⁵ Obtaining a DEA registration is done by completing a new application form (ie, DEA Form-224, see also form instructions).⁶ Once a new registration is granted (usually within 4 to 6 weeks after application submission), providers may only engage in controlled substance-related activities that are “authorized under state law for the jurisdiction in which their practice is located.”³ When federal law or regulations conflict with state law or regulations, the provider must abide by the more stringent requirements.
Providers must maintain separate DEA Certificates of Registration (with certificate renewal required every three years) at each location in which they preserve supplies, administer, or directly dispense controlled substances.³ DEA registration is based on an individual provider’s state license; therefore, controlled substance dispensing outside the state is not allowed. A DEA registration or renewal may be denied or, once granted, suspended or revoked. Reasons for denying, suspending, or revoking a registration include:
Falsifying the application for the registration
Prior conviction of a felony related to a controlled substance or a List I chemical
Suspension, revocation, or denial of a state license
Committing an act that renders registration inconsistent with the public interest
Exclusion from Medicare or Medicaid programs.
Whether or not an act is inconsistent with the public interest is determined by weighing factors such as state licensing board or professional disciplinary authority recommendations, the applicant’s experience in dispensing or conducting research involving controlled substances, compliance with laws regarding controlled substances, and a prior conviction record related to any aspect of controlled substances (ie, manufacture, distribution, or dispensing).³
Providers who are employed in hospitals or other healthcare facilities may practice under their institution’s DEA registration number.³ This practice is allowed provided that the following conditions are met:
handling of controlled substances is performed in the “usual course of professional practice”
the provider has appropriate authorization within their state of practice
the institution has verified that the provider is permitted to partake in controlled substance-related activities in the state
the provider acts only within their “scope of employment”
the institution has authorized the provider to work under its registration and assigned the provider a specific internal code.
The institution must maintain a listing of these authorized internal codes and names of the corresponding provider.
Prescriptions
General Requirements
In order for a prescription for a controlled substance to be considered valid, it must be “issued for a legitimate medical purpose by a registered practitioner acting in the usual course of sound professional practice.”⁷ All of the following must be included in a prescription for a controlled substance:
Issue date
Name and address of patient
Name, address, and DEA registration number of practitioner
Drug name
Strength of drug
Dosage form (eg, tablet, suspension)
Quantity prescribed
Directions for use
Refills (if authorized)
Signature of the prescriber
Quantity and Time Limits
There are no federal quantity limits on Schedule II prescriptions; however, the amount dispensed must be consistent with the requirement that a controlled substance prescription be issued only for a legitimate medical purpose.³˒⁴ In addition, there is no federal time limit on when a Schedule II prescription must be filled after being signed by a prescriber; however, pharmacists may need to determine if a prescription is still needed by the patient depending upon the prescription issue date.
Phoned-in, Faxed, or Written
Phoning in a prescription for a Schedule II medication may only be done in an emergency situation.⁷ If this is done, the prescriber must follow-up the phone prescription with a written prescription to the pharmacy within 7 days. Faxed Schedule II prescriptions are generally permitted; however, the pharmacist must receive the original, signed written prescription before actual dispensing of the Schedule II controlled substance to the patient.³˒⁴ There are three situations in which a faxed Schedule II prescription may serve as an original written prescription:
The HCP is prescribing a Schedule II narcotic to be compounded for direct administration to a patient by intravenous, intramuscular, subcutaneous, or intraspinal infusion.
The HCP is prescribing Schedule II medications to patients within a long-term care facility, which are normally filled and delivered to the patients within the facility by the pharmacy.
The HCP is prescribing Schedule II medications to a patient in hospice care as certified by Medicare or licensed by the state.
Prescriptions for controlled substances falling under Schedules III to V may be written, orally communicated, or faxed to the pharmacy.
Refills
Not all prescriptions for controlled substances can be refilled.⁷ Schedule II medications may not be refilled; a new prescription must be written every time. Medications classified as Schedule III or IV may be refilled up to 5 times within a 6-month period. Schedule V medications may be refilled as authorized by the prescriber.
On December 19, 2007, a new DEA regulation became effective, allowing for a prescriber to issue multiple prescriptions authorizing an individual patient to receive a total of up to a 90-day supply of a Schedule II controlled substance.³˒⁴ However, this may only occur if the following conditions are met:
Each prescription must be written for a legitimate medical purpose by an authorized prescriber during the usual course of professional practice
The HCP must indicate on each prescription the earliest date on which the prescription can be filled by the pharmacy; an exception to this rule would be for the first prescription if the prescriber intends for that prescription to be filled immediately
The HCP determines that providing multiple Schedule II prescriptions to the patient does not increase the risk of diversion or abuse
State law allows for the issuance of multiple prescriptions
The individual prescriber complies fully with all other applicable requirements under the Controlled Substance Act and the Code of Federal Regulations, as well as any additional requirements under state law.
Electronic Prescriptions
In 2010, the DEA began to officially address the issue of electronic controlled substances prescriptions. On March 31 of that year, the agency published a final rule on electronic prescriptions for controlled substances with request for comment in the Federal Register.⁸ This rule became effective on June 1, 2010 and provided HCPs with the option of writing prescriptions for controlled substances electronically.⁹ The new regulations do not mandate that providers prescribe controlled substances using only electronic prescriptions nor do they require pharmacies to accept electronic prescriptions for controlled substances when dispensing. The contents of an electronic controlled substances prescription cannot be altered during electronic transmission between the healthcare provider and the pharmacy; however, content changes may be made to a prescription upon pharmacy receipt. Although electronic prescribing has increased dramatically in general, electronic ordering of controlled substances remains underutilized primarily due to implementation and interoperability concerns.¹⁰
Discussion
Since a variety of Schedule II controlled substances are opioid analgesics, this author would be amiss not to address the current opioid crisis as part of this CSA review. The 2016 Centers for Disease Control and Prevention (CDC) guideline on prescribing opioids for chronic pain largely lies outside of active cancer, palliative care, and end-of-life care settings.¹¹ However, this document does discuss the appropriate initiation and continuation of opioids in primary care, including optimal opioid selection, dosage, duration, follow-up, discontinuation, and overall risks of therapy.
When initiating opioids for chronic pain, the guideline recommends prescribing the lowest effective dosage of immediate-release versus extended-release/long-acting opioids. Although caution should be exercised when prescribing opioids at any dosage level, providers are recommended to assess individual benefits and risks when increasing an opioid dosage to ≥ 50 morphine milligram equivalents (MME)/day. Additionally, the guideline recommends avoiding increasing opioid dosages to ≥ 90 MME/day or, alternatively, providing a justification for dosage titration above this level (again: targeting the primary care setting not specialty-based pain management).
Prescribing clinicians should consider the appropriate duration of opioid therapy. Initial management of acute pain with opioids can serve as a “jumping off point” resulting in chronic administration. For acute pain, ≤ 3 days of opioid therapy is generally sufficient and > 7 days is rarely necessary. The quantity of opioids prescribed should reflect the expected duration of therapy. Providers should also regularly evaluate the benefits and harms of chronic opioid therapy with the patient and consider when to optimize other treatments, taper dosages, or taper and discontinue therapy when risks outweigh benefits.
Although uptake of the guidelines in clinical practice has occurred rapidly, the CDC has noted situations where misapplication of recommendations may increase patient risk.¹²˒¹³ For instance:
The guideline is intended to aid primary care clinicians (PCPs) with the management of chronic pain in adults, yet, its recommendations have been applied to populations outside its scope, such as those with active cancer or sickle cell crises.
The guideline does not state that opioids prescribed at higher dosages should be discontinued; however, the recommendations within the guideline have been used to justify hard limits or “cutting off” opioids. Additionally, policies that mandate the use of hard limits conflict with the patient-centered approach of the guidelines that emphasizes an individualized assessment of benefits, risks, circumstances, and needs for each patient.
Inappropriate application of the guideline’s opioid dosage recommendations to patients currently administered, or initiating, medication-assisted treatment for opioid use disorder. The dosage recommendations within the guideline do not apply to this patient population.
Beyond the guideline, providers may find these additional CDC resources helpful regarding opioid therapy.
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