As an integral part of the health care delivery system, pharmacies present many high-priority issues for hospitals. CHA works with the California Society for Health Systems Pharmacists to assure legislation and regulations pertaining to the administration of pharmaceutical products are safe for patients, cost-effective and realistic.
CHA advocates for technology that is internationally accepted by drug manufacturers and has reasonable implementation timelines. For example, CHA supports an electronic-pedigree system, which would make changes to the drug distribution process to protect against counterfeit, misbranded, adulterated or diverted drugs. CHA also coordinates issues between pharmacists and other disciplines, such as nursing, in hospitals.
As an integral part of the health care delivery system,
pharmacies present many high-priority issues for hospitals. CHA
works with the California Society for Health Systems Pharmacists
to assure legislation and regulations pertaining to the
administration of pharmaceutical products are safe for patients,
cost-effective and realistic.
CHA advocates for technology that is internationally accepted by
drug manufacturers and has reasonable implementation timelines.
For example, CHA supports an electronic-pedigree system, which
would make changes to the drug distribution process to protect
against counterfeit, misbranded, adulterated or diverted drugs.
CHA also coordinates issues between pharmacists and other
disciplines, such as nursing, in hospitals.
The Health Services Advisory Group’s Hospital Improvement
Innovation Network will hold
conferences over the next two months — June 25 in
Pasadena and July 10 in Sacramento — focused on combating
the opioid crisis.
The California Department of Public Health (CDPH) earlier this
week released All
Facilities Letter 19-19, which updates its application
process for new or remodeled pharmacy clean rooms and mobile
sterile compounding units (MSCUs). Notably, CDPH will no longer
accept incomplete applications for pharmacy clean rooms or MSCUs.
CDPH states the update is in response to Assembly Bill 2978
(Chapter 992, Statutes of 2018), which requires CDPH to review or
deny applications within 100 days of receipt.
Cal Hospital Compare, a nonprofit performance reporting
initiative, will launch an opioid safety designation program for
hospitals later this month, intended to accelerate improvement
and recognize California hospitals’ efforts to combat the opioid
epidemic. A series of
five no-cost webinars– the first to be held May
9 at 11 a.m. (PT) – will explain a
self-assessment tool integral to the new designation, and
will feature peer-to-peer learning on a variety of safe opioid
In response to providers’
recent challenges implementing new requirements for opioid
prescriptions, the governor has signed into law a bill that
allows a transition period before the requirements become
The Drug Enforcement Administration has moved Epidiolex
from Schedule I to Schedule V. According to
All Facilities Letter 19-06, issued last week by the
California Department of Public Health, cannabis-derived drugs
that are approved by the Food and Drug Administration and that
have no more than 0.1 percent residual tetrahydrocannabinols will
be moved to Schedule V. Currently, only Epidiolex meets
those requirements. Drugs that do not meet these criteria may not
be prescribed or dispensed.
Beginning Feb. 23, the Department of Health Care Services (DHCS)
will implement a new fee-for-service reimbursement methodology
for covered outpatient drugs. The methodology will reimburse the
lower of the actual acquisition cost (as determined by the
Centers for Medicare & Medicaid Services), the federal upper
limit, the maximum allowable ingredient cost, and the pharmacy’s
usual and customary charge. For more details about the changes,
Last week, CHA
shared information about problems some providers have had in
implementing a new state law requiring controlled substance
security prescription forms to include a unique serial number.
This week, the California Board of Pharmacy released updated
frequently asked questions about the law’s requirements and
As of Jan. 1, controlled substance security prescription forms
must include a new, unique serial number in a format approved by
the Department of Justice. However, the new requirement
does not allow for a transition period during which
providers would be allowed to use the previously approved form,
and those who do not have access to the new forms have been
forced to choose between denying care and risking action against
Prescribers are now required to offer naloxone hydrochloride, or
another drug approved by the Food and Drug Administration, to
patients who experience certain conditions related to opioid
depression. The Medical Board of California has
asked questions to assist providers in implementing the new
requirements, which took effect Jan. 1.
The California section of the American College of Emergency
Physicians has updated its opioid
safe prescribing guidelines to reflect expanded use of
medication-assisted treatment in emergency departments. Notably,
the guidelines no longer prohibit treating addiction in the
As required by Assembly Bill 40 (Chapter 607, Statutes of 2017),
the Department of Justice has developed a method of system
integration through which approved providers may use a qualified
health information system to access the Controlled Substance
Utilization Review and Evaluation System (CURES) database.
The Centers for Disease Control and Prevention has updated its
Hepatitis B vaccine information statement to note that a two-dose
series is available. Stocks of the existing edition may be used
up before switching to the updated version. To subscribe to the
CDC’s email notification service about vaccine information
CHA and the California Society of Health-System Pharmacists have
finalized a tool to assist pharmacy staff in complying with
sterile compounding regulations. Developed by CHA’s Medication Safety Committee,
the attached grids interpret U.S. Pharmacopeia (USP) 797 and
proposed USP 800 requirements, as well as California Board of
Pharmacy sterile compounding regulations. The grids also
detail requirements related to temperature and monitoring,
frequency of documentation and cleaning, facilities and
engineering controls for hazardous and non-hazardous drugs,
competency and training, and garbing. More resources can be found
in CHA’s Medication
The Centers for Disease Control and Prevention has released a
alert notifying clinicians that three patients in the U.S.
have been diagnosed with leptospirosis after travel to Israel.
Leptospirosis is a bacterial disease that can be spread through
contact with infected animals or contaminated water sources.
Early symptoms include fever, headache, chills, muscle aches,
vomiting, diarrhea, cough, jaundice or rash. Clinicians should
consider this diagnosis for patients presenting with those
symptoms who have traveled to northern Israel since July 1.
frequently asked questions document from the Medical Board of
California addresses key concerns related to mandatory
consultation of the Controlled Substance Utilization Review and
Evaluation System (CURES). CURES is a database that contains
records of prescriptions for Schedule II, III and IV controlled
substances dispensed in the state. The Medical Board document
defines “mandatory use,” clarifies the actions that constitute
consultation, and explains whether prescribers may use proxy or
delegate staff to meet these requirements.
reported in CHA News, Senate Bill 482 (Chapter 708,
Statutes of 2016) required health practitioners to consult their
patients’ histories in CURES before prescribing them a Schedule
II, III or IV controlled substance for the first time, and then
at least once every four months as long as the prescription
continued to be renewed. Consultation is not required when
controlled substances are administered to inpatients or to
certain other patients treated in a health facility. The bill’s
requirements take effect Oct. 2.
Two potential over-the-counter influenza diagnostic tests are
moving into advanced development with support from the U.S.
Department of Health and Human Services, according to a
press release. Both tests are designed to be inexpensive,
easy for consumers to use and provide results within 25 minutes.
In addition, both will enable patients who test positive to
receive a telemedicine consult and, if needed, a prescription for
antiviral drugs — all without leaving their house. Developers
plan to create devices that could test for other viruses,
including Zika and HIV.
The second segment of a four-part online
training course on antibiotic stewardship is now available
from the Centers for Disease Control and Prevention (CDC). The
newly released segment consists of four modules focused on
outpatient antibiotic use in the U.S., offering information on
barriers to appropriate outpatient antibiotic
prescribing; the core elements of outpatient antibiotic
stewardship and evidence-based strategies to implement those
elements; and training for communicating with patients when
antibiotics are not necessary. Completing the training
qualifies for certain continuing education credit and counts as
an improvement activity under Medicare’s new Merit-based
Incentive Payment System.
For more antibiotic stewardship resources, visit the
Citing increased prevalence of fentanyl and other synthetic
opioids in the illicit drug market, the Trump administration has
released the attached safety guidelines for first responders that
emphasize how to protect themselves in the field. Developed by a
federal interagency work group that considered stakeholder input,
the recommendations cover three categories: how to protect
oneself from exposure, what to do when exposure occurs and what
to do if they or their partners exhibit signs of intoxication.
Specifically, first responders are reminded to utilize personal
protective equipment; avoid actions that may cause fentanyl
powder to become airborne; avoid using hand sanitizer in the
event of exposure, as it may exacerbate absorption; and
administer naloxone according to protocols. For more information,
In January 2017, the California Board of Pharmacy (BoP)
established new requirements for hospitals performing
sterile compounding. In addition, the Office of Statewide Health
Planning and Development’s Facilities Development Division and
the California Department of Public Health (CDPH) Licensing and
Certification Program must review physical plant and program
changes that hospitals must make to comply with the new BoP
In May, CDPH released an All
Facilities Letter clarifying requirements for new or
remodeled pharmacy clean rooms and use of mobile sterile
compounding units in general acute care hospitals. According to
the letter, hospitals must obtain CDPH approval for all new or
remodeled pharmacy clean rooms under the hospital’s license.
Hospitals must also obtain CDPH approval — including program
flexibility approval — to temporarily use mobile sterile
compounding units. CDPH advises hospitals to submit applications
to the Centralized Applications Unit 120 days prior to when they
anticipate completion of the new or remodeled pharmacy, and
to clearly mark that the application is for sterile compounding.
In addition, CDPH advises hospitals to contact the CDPH Pharmacy
Consultant Unit at LNCPharmCleanRoom@cdph.ca.gov 90
days prior to anticipated completion.
new annual report from the Food and Drug Administration (FDA)
highlights 39 drug and biological product shortages that began in
2017, up from 26 new shortages in 2016. The increase is
partially due to disruptions caused in the fall of 2017 by
Hurricanes Harvey, Irma and Maria. According to the report,
federal actions have resulted in manufacturers notifying the FDA
of shortages earlier than in previous years, allowing the agency
additional time to work with stakeholders to maintain treatment
options and prevent shortages. However, FDA notes that drug
shortages continue to pose a significant public health
The report also notes 41 ongoing shortages from previous years.
FDA says it will “continue to prioritize this important public
health issue, working to ensure the availability of necessary
drugs and biological products for the American public.”