Innovations-Magazine-May-2023 - 15

PROFESSIONAL AFFAIRS UPDATE
FDA Restricts Unlawful
Importation of Xylazine Amid
Public Health Concern
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
FDA's website under news releases.
FDA Approves First OTC
Naloxone Nasal Spray
FDA approved Narcan® 4 mg naloxone
hydrochloride nasal spray to be sold overthe-counter
(OTC), making it the first
naloxone product that will be available
without a prescription. Naloxone is a
lifesaving 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.
Drugs Containing Cannabis
Addressed by FDA
Final Guidance
FDA has published a final guidance on
several topics related to the development
of human drugs containing cannabis
or cannabis-derived compounds. The
document, Cannabis and Cannabis-Derived
Compounds: Quality Considerations for
Clinical Research, Guidance for Industry,
includes US Pharmacopeia chapters
on quality testing; identifies relevant
International Council for Harmonisation
guidelines; includes considerations for
devices used in combination with a drug;
and addresses the calculation of delta-9tetrahydrocannabinol
content that is needed
to determine the control status for cannabis
and cannabis-derived compounds. The
agency is continuing to investigate various
quality considerations for these drugs. FDA's
guidance documents can be found on FDA's
Regulatory Information page.
VA Releases Guidelines on
Buprenorphine for Patients
With Chronic Pain
The Department of Veterans Affairs
(VA) and the Department of Defense
(DOD) have developed new guidelines
to support prescribing buprenorphine for
patients taking daily opioid analgesics for
chronic pain. The guidelines argue that
buprenorphine poses a lower risk of misuse
or overdose compared to other opioids.
VA officials and the DOD approved the
clinical practice guidelines in May 2022,
and researchers have since published
additional evidence regarding the benefits
of buprenorphine. Researchers also
noted that chronic pain patients should
undergo behavioral evaluations and receive
educational intervention on opioids and
pain management. More information about
the guidelines can be found in the American
College of Physicians' February 2023 issue of
Annals of Internal Medicine.
Children More Likely to Show Signs
of Influenza, Says CDC Report
A study published in Centers for Disease
Control and Prevention's (CDC's) Morbidity
and Mortality Weekly Report (MMWR)
revealed that children were more likely to be
hospitalized and show symptoms associated
with influenza than adults in fall 2022.
Among individuals who took a test for
influenza at outpatient clinics, children were
twice as likely as adults to receive a positive
influenza test result. Patient surveys, data
from medical surveillance networks, and
whole-genome sequencing of influenza virus
specimens were collected to assess influenza
activity and secondary illness risk in 14 of 95
Tennessee counties. Details of the study can
be found in CDC's January 2023 MMWR.
Telemedicine Program
Shown to Foster Maintenance
of OUD Treatment
Researchers at the University of Pennsylvania
found that more than half of patients who
were prescribed buprenorphine through a
telemedicine program continued with their
opioid use disorder (OUD) treatment at least
a month later. The program, CareConnect,
was established during the pandemic and
is a partnership between the University
of Pennsylvania's 24/7 urgent care, called
Penn Medicine OnDemand, and a team of
substance use navigators. According to the
New England Journal of Medicine Catalyst
study, 89% of patients enrolled in the
program filled their first prescription for
OUD and 55% of patients continued to have
an " active prescription " for the medication 30
days after their first prescription, indicating
that they were continuing treatment.
Additional information about the study
is available in the New England Journal of
Medicine Catalyst December 2022 issue.
'Know Your Dose' Campaign
Continues to Provide Consumer
Education Tools
The 2023 " Know Your Dose " campaign by
the Acetaminophen Awareness Coalition is
focused on increasing consumer knowledge
and awareness of how to safely use
acetaminophen and the risks involved in
taking more than the advised directed dose.
The organization developed a toolkit that
includes social media posts and newsletter
content to help its members inform patients
on how to safely take fever and pain
medications that contain acetaminophen.
The " Know Your Dose " Cold and Flu toolkit
can be downloaded at www.knowyourdose
.org/the-acetaminophen-awareness-coalition.
MAY 2023 | 13
https://www.cdc.gov/mmwr/volumes/72/wr/mm7203a1.htm?s_cid=mm7203a1_w https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cannabis-and-cannabis-derived-compounds-quality-considerations-clinical-research-guidance-industry https://www.fda.gov/news-events/press-announcements/fda-takes-action-restrict-unlawful-import-xylazine https://catalyst.nejm.org/toc/catalyst/3/12 https://www.acpjournals.org/toc/aim/176/2 https://www.knowyourdose.org/the-acetaminophen-awareness-coalition/
Innovations-Magazine-May-2023

Table of Contents for the Digital Edition of Innovations-Magazine-May-2023
