Ketamine Practices

Compounded ketamine therapy presents a viable alternative for parents grappling with conditions resistant to FDA-approved treatments, and yet is not and should not be a first-line therapy. Pharmacists must also recognize that ketamine is a controlled substance medication with risks of addiction, abuse, and diversion. Diligence is essential to ensure the responsible use and safeguard against misuse of these therapeutic options.

These best practices apply to the following circumstances in which manufactured ketamine is prescribed or administered off label and when compounded ketamine is being prescribed and/or administered off label for certain indications:

Commercially available intravenous/intramuscular or compounded IV/IM ketamine administered in-clinic to a specific patient for the treatment of a specific, legitimate medical indication. (The patient is monitored for potential adverse effects by a practitioner during the treatment.)
Compounded ketamine nasal sprays, rapid dissolve tablets, troches, suppositories, or other dosage forms prescribed and dispensed to a specific patient for the treatment of a specific, legitimate medical indication.

Pharmacist Legal Obligations

Know DEA controlled substance laws and controlled substance laws in the individual state where the drug is dispensed, as well as current federal and state regulations regarding controlled substance prescribing if working with telehealth providers.
Understand a pharmacist’s corresponding responsibility when dispensing controlled substance prescriptions.
Determine whether, under state law, controlled substance prescriptions require a signature upon delivery, and comply accordingly.

Diversion Concerns

Utilize Prescription Drug Monitoring Programs (PDMPs) to review the patient’s prescription history and identify any signs of misuse or diversion. The PDMP should be checked at every filling of the prescription.
Record all controlled substances dispensed, including ketamine, in the appropriate states’ Prescription Drug Monitoring Program.
Conduct thorough patient and prescriber verification to ensure legitimacy and appropriateness of the prescription. Verify a legitimate patient-prescriber relationship exists. Know your patient and your prescriber. Consider the prescriber’s scope of practice when evaluating the validity of the prescription.
Exercise extreme caution with high volumes, multiple refills, or early-refill requests, and always investigate further if these patterns are observed.
Monitor the pharmacy’s inventory of ketamine API and any anticipatorily compounded ketamine products for any potential discrepancies, and investigate immediately if an irregularity is discovered.

Dosing Limits

Evaluate each prescription carefully, adhering to these best practices, and in light of the pharmacist’s corresponding responsibility.
Establish appropriate dosing considerations for ketamine based on clinical guidelines, available evidence, and knowledge of the patient’s specific needs.
Use professional judgment, clinical literature, and communication with the prescriber when assessing dosing for each condition, considering individual patient factors and treatment goals. Do not utilize arbitrary limits.

Dosage Forms

Consider utilizing alternative dosage forms, such as capsules containing abuse-deterrent excipients, to enhance safety.
Consider dispensing all ketamine products in a child-resistant container, even if the resident state does not require it, to prevent inadvertent access to the medication by children or pets.

Documentation

Properly document all aspects of the compounding and dispensing process, particularly for dosages higher than your pharmacy’s normal dispensing for ketamine, unusual directions for use, or dosing escalations, to ensure accountability and traceability.
Document drug-drug interactions, early-refill conversations with providers, and anything that may constitute a “red flag,” along with everything else that must be documented during the drug utilization review process.

Patient Education

Provide comprehensive counseling to patients on the proper use, potential side effects, and safety precautions for ketamine therapy. They may include written and verbal communication.
Supply written educational materials to reinforce key points and serve as a reference for patients.
Educate the patient on side effects of ketamine, emphasizing restrictions on driving or combining with other medications or alcohol.

Constructive Transfer

Adhere to the regulatory requirements for constructive transfer, ensuring that patient-specific compounded ketamine prescriptions are delivered directly to the patient or their authorized agent, rather than to the prescriber/prescriber’s office.
Understand that if a controlled drug is prescribed for a specific patient and the prescriber directs it to delivered for administration in their office, the DEA has indicated it could use enforcement discretion*
* if the pharmacy dispenses only a single dose.