COUNTER POINTS
A Quarterly Newsletter of the State Board of Pharmacy
First Over-the-Counter Naloxone Spray Approved
The FDA approved the Narcan® 4 mg naloxone hydrochloride nasal spray to be sold over-the-counter (OTC), making it the first naloxone product that will be available without a prescription.
Naloxone is a life-saving medication that reverses the effects of opioid overdoses. The product will include instructions for consumers regarding how to use the drug safely and effectively without the supervision of a health care professional.
While it may take months for the medication to transition from prescription status to OTC, the agency has plans to work with all stakeholders to ensure the continued availability of other naloxone nasal spray products during this time.
Additional information is available on FDA’s website
under news releases
More News from the Food and Drug Administration
Heightened Scrutiny
on Xylazine Ingredients
as Illicit Use Grows
The Food and Drug Administration (FDA) announced that it is restricting the unlawful entry of xylazine active pharmaceutical ingredients and finished dosage form drug products into the United States to address growing concerns of the chemical appearing in drugs such as illicitly manufactured fentanyl, methamphetamine, and cocaine.
The agency warns that individuals who inject products containing xylazine can experience life-threatening symptoms, such as depressed breathing, blood pressure, heart rate, and body temperature. Individuals may also develop severe skin wounds and patches of dead and rotting tissue that can easily become infected and, if left untreated, may lead to amputation.
Shipments of xylazine will undergo heightened FDA scrutiny to ensure that the imports of the drugs containing xylazine into the US are intended for legitimate veterinary supply. Veterinarians use xylazine to sedate large animals, such as horses and deer.
More information is available on the FDA's website under news releases.
Guidance Issued as Part of DSCSA
The FDA released the final guidance document, Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act, as part of the preparation for implementation of the Drug Supply Chain Security Act (DSCSA).
The terms “counterfeit,” “diverted,” “stolen,” “fraudulent transaction,” and “unfit for distribution” are clarified in the definitions of “suspect product” and “illegitimate product” to help trading partners in meeting verification obligations. This guidance replaces the previous draft guidance of the same name.
Permanent Telemedicine Rules
Considered for Controlled Medications
The Drug Enforcement Administration (DEA) has proposed permanent rules for prescribing controlled medications through telemedicine, which were established during the coronavirus disease 2019 pandemic.
The proposed rulesaddress telemedicine consultations by a medical practitioner who has never conducted an in-person evaluation of a patient and that would result in the prescribing of a controlled medication.
Under these circumstances, a medical practitioner would be allowed to prescribe a 30-day supply of Schedule III-V nonnarcotic controlled medications or a 30-day supply of buprenorphine for the treatment of an opioid use disorder without an in-person evaluation or referral from a medical practitioner who has conducted an in-person evaluation, as long as the prescription is otherwise consistent with any applicable federal and state laws.
Covid Telehealth flexibilities,
Q&A available to practitioners
The DEA and SAMHSA are extending the COVID telemedicine flexibilities through November 11, 2023. This Q&A summarizes the COVID telemedicine flexibilities, which in brief exempts telehealth practitioners from the requirement to obtain a DEA license in each state for which they treat patients via telemedicine.
The DEA had proposed rule updates in February which are summarized here
PREP ACT for COVID-19 Countermeasures extended
U.S. Secretary of Health and Human Services Xavier Becerra on May 9 signed the 11th amendment to the declaration under the Public Readiness and Emergency Preparedness (PREP) Act for COVID-19 Medical Countermeasures.
The Secretary issued this amendment to clarify that COVID-19 continues to pose a credible risk of a future public health emergency, add two new limitations on distribution, extend the time period of coverage for certain Covered Countermeasures and Covered Persons, clarify the time period of coverage for Covered Persons authorized under the Declaration, and extend the duration of the Declaration to December 31, 2024.
Read full details of the amendment in the Federal Register Notice online.
The end of the COVID-19 Public Health Emergency Declaration does not automatically terminate PREP Act coverage. To learn more, view the COVID-19 PREP Act FAQs online.
Legislative Updates
SB23-144: Prescription drugs for chronic pain
On May 4, 2023, Governor Jared Polis signed SB23-144: Prescription Drugs for Chronic Pain, into law.
Under this bill, a health-care provider may prescribe, dispense, or administer a schedule II,III, IV or V controlled substance to a patient in the course of their treatment for a diagnosed condition causing chronic pain. A healthcare provider is not subject to discipline for prescribing these drugs as long as the provider keeps an accurate record of the purpose, use, prescription, and disposal of the controlled substance; if they write accurate prescriptions; and if they prescribe medications in accordance with legitimate medical purpose in the course of professional practice.
Furthermore, health care providers acting in good faith based on the needs of patients diagnosed with chronic pain are not subject to discipline solely for prescribing a dosage that equates to an adeviation from morphine milligram equivalent dosage recommendations, or from thresholds specified in state or federal opioid prescribing guidelines.
Health-care providers treating a patient by prescribing the aforementioned drugs should not be required to taper a patient’s medication dosage solely to meet predetermined morphine milligram equivalent dosage recommendations if the patient is stable and compliant with the treatment plan.
A pharmacy, carrier, or pharmacy benefit manager shall not have a policy in place that requires the pharmacists to refuse to fill a prescription for an opiate issued by a health-care provider with authority to prescribe opiates, or solely because the prescription order exceeds a predetermined morphine milligram equivalent dosage recommendation or threshold.
HB23-1195: Automated pharmacy dispensing system
Gov. Polis signed HB23-1195: Automated Pharmacy Dispensing System into law on May 1.
This bill allows prescription drug outlets to dispense prescription drugs through an automated pharmacy dispensing system. If a prescription drug outlet (PDO) chooses to use automated pharmacy dispensing systems, the following requirements must be met:
The systems must be registered through the Board of Pharmacy;
A pharmacist must perform all clinical services as part of the dispensing process;
The PDO must ensure that each system clearly displays the PDO registration number and contact information;
Systems that dispense controlled substances must be located at same sites as PDOs registered by the DEA;
Records must be maintained of the pharmacist responsible for verifying the accuracy of the prescription dispensed, directions for the use of the drug, and counseling services provided;
Assurances must be made that confidentiality of personal health information is maintained; and,
The PDO must ensure that the system is accessible to persons with disabilities.
Furthermore, the bill specifies that a PDO that operates outside of a retail business can only operate the dispensing system outside of the hours that the PDO is closed.
Automated pharmacy dispensing systems can only dispense prescription drugs upon authorization of a pharmacist acting on behalf of the PDO. PDOs are tasked with developing, implementing, and maintaining written policies and procedures to ensure proper and safe functioning of the dispensing systems, and will review those rules annually.
SB23-162: Increase access to pharmacy services
Gov. Polis signed SB23-162: Increase Access to Pharmacy Services into law on May 5.
Under this bill, pharmacists may delegate specified tasks described in statute (12-280-103 (38.5) (a); 12-280-103 (38.5) (a) (IX)) to pharmacy technicians who are under a pharmacist’s supervision in a prescription drug outlet under the charge of a pharmacist.
This bill specifies that a pharmacist may supervise up to six persons who are either pharmacy interns or pharmacy techs. However, at central fill pharmacies, a pharmacist may supervise up to eight persons who are pharmacy interns or pharmacy techs, with more specificity outlined in the bill.
Finally, this bill grants a pharmacist or pharmacy, which is enrolled in good standing with the vaccines for children program administered by the Department of Public Health and Environment, that dispenses or administers vaccinations to children under 19 years of age the ability to seek reimbursement for the dispensing or administration of vaccines under the medical assistance program either as a pharmacy benefit or as a medical benefit.
HB23-1071: Licensed psychologist prescriptive authority
Gov. Polis on March 3 signed into law HB23-1071: Licensed Psychologist Prescriptive Authority. This bill allows a licensed psychologist to prescribe and administer psychotropic medications if the licensed psychologist holds a prescription certificate issued by the board.
The bill likewise requires a prescribing psychologist to maintain a collaborative relationship with the health-care provider who oversees the client’s general medical care. Lastly, the bill requires DORA to annually collect information regarding prescribing psychologists and to share with COPRRR for sunset reviews.
The bill also specifies that one member of the Colorado State Board of Psychologist Examiners must be a prescribing psychologist.
Questions?
dora_pharmacyboard@state.co.us