Guideline/Drug Updates and Errata

Continuing education (CE) requirements for pharmacist licensure renewal have been updated.

Pharmacists who prescribe schedule II controlled substances must complete at least 1 hour of CE every 4 years pertaining to the risk of addiction associated with these medications.

Controlled substance inventory reports must be prepared using an exact physical count, not an estimate, for all federal controlled substance schedules (i.e., schedules II–V) that a pharmacy has in stock (both unopened and opened containers).

Prior to this law change, an estimated count was permissible for opened containers of schedule III–V controlled substances based on the number of dosage units.

The Notice to Consumers poster has been updated. The poster is now titled “Talk to the Expert” and must replace the “Ask Your Pharmacist!” poster.

The content of the poster has been updated to caution consumers to “check” for a list of key information regarding their prescription before leaving the pharmacy. The poster continues to notify consumers of their rights as a patient at the pharmacy.

The new poster also includes a QR code that links consumers to other language translations of the poster. If the poster is displayed using a video screen, the QR code must still be capable of being read and displayed for sufficient time for consumers to access the code.

The California Department of Public Health has issued a statewide standing order for epinephrine which authorizes a CA school, school district, or county office of education to obtain epinephrine auto-injectors for K-12 schools (ie, elementary, middle, junior high, and high schools).

The standing order is acceptable at all pharmacies throughout CA to dispense epinephrine auto-injectors. The maximum number of auto-injectors is four per school per calendar year. If used, these can be refilled (which does not count toward the quantity limit).

A pharmacist can furnish oral drugs approved or authorized by the FDA for COVID-19 to a patient that has had a positive test for SARS-CoV-2. When furnishing, the pharmacist must:

1. Use evidence-based clinical guidelines published by the FDA.
2. Notify the patient’s primary care provider or enter the information in a shared patient record system. If the patient does not have a primary care provider, the pharmacist must provide the patient with a written record of what they received and advise the patient to consult a physician.
3. Document the drug(s) and quantity furnished and any testing provided in the patient’s pharmacy record, and keep this documentation for 3 years.

The FDA has approved a new over-the-counter (OTC) naloxone product (brand name RiVive) indicated for the emergency treatment of known or suspected opioid overdose. RiVive will be available as a 3-milligram nasal spray.

The “naloxone protocol” has been updated to the “opioid antagonist protocol” for the indication of opioid reversal. Important changes include:

• Language regarding screening of potential recipients has been removed (ie, the first 2 bullets on page 75).
• Pharmacists are no longer required to give the recipient a board-approved Fact Sheet.

The law for furnishing HIV pre-exposure prophylaxis (PrEP) has been updated as follows:

1. Pharmacists are authorized to furnish up to a 90-day supply of approved medications to a single patient every two years (if eligibility criteria are met).
2. A pharmacist may furnish subsequent 90-day courses of PrEP if the pharmacist ensures that the patient receives testing and follow-up care consistent with CDC guidelines, documents the services provided in the patient’s record and notifies the patient’s primary care provider that these requirements were completed.

Restrictions for a take-home supply of methadone for opioid use disorder (OUD) have been simplified and are now permissive of larger quantities.

Opioid Treatment Programs are allowed to dispense up to a 28-day supply of methadone for unsupervised self-administration (ie, “take-home”) to qualifying patients for treatment of OUD. Medical practitioners are responsible for determining which patients qualify for a take-home supply based on criteria listed in the regulation (eg, absence of known recent diversion activity, regularity of attendance for supervised methadone administration) in addition to other factors that indicate that the benefits of unsupervised doses outweigh the risks.