The Medication Safety Committee provides leadership within the health care community to promote the highest standards related to the safe and effective use of medications. The committee provides a forum for diverse multi-disciplinary health care organizations, including health care delivery organizations, patient safety organizations, discipline-specific professional associations/organizations and regulatory agencies in the state of California.
The Medication Safety Committee also acts as a source of medication safety expertise, providing a venue for the coordination of medication safety activities and making recommendations related to medication safety legislation and regulations.
For more information, contact BJ Bartleson, vice president, nursing & clinical services, at (916) 552-7537.
The Medication Safety Committee provides leadership within the
health care community to promote the highest standards related to
the safe and effective use of medications. The committee
provides a forum for diverse multi-disciplinary health care
organizations, including health care delivery organizations,
patient safety organizations, discipline-specific professional
associations/organizations and regulatory agencies in the state
The Medication Safety Committee also acts as a source of
medication safety expertise, providing a venue for the
coordination of medication safety activities and making
recommendations related to medication safety legislation and
For more information, contact BJ Bartleson, vice
president, nursing & clinical services, at (916) 552-7537.
The United States Pharmacopeia (USP) has released newly revised
standards to assist health care practitioners in
consistently producing high-quality compounded medicines that are
the right strength and free of contaminants. The final
825, and USP
General Chapter 800 standards will take effect Dec.
Senate Bill 1254 (Chapter 697, Statutes of 2018), hospitals
must establish criteria for high-risk patients and complete a
medication profile for those patients. To better understand
how this new requirement will impact patient safety, CHA and
California Health System Pharmacists members will undertake a
quality improvement project.
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
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.
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.
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
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.
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.
The U.S. Drug Enforcement Agency (DEA) has released its 2017
Drugs of Abuse: A DEA Resource Guide. The guide,
intended to provide comprehensive information about the most
commonly abused and misused drugs in the United States, has been
updated to reflect new and emerging trends such as fentanyl,
other opioids and synthetic drugs. In addition to providing an
in-depth discussion of the Controlled Substances Act, the guide
includes chapters on narcotics, stimulants, depressants,
hallucinogens and designer drugs.
More and more, healthcare professionals and regulators are
turning their focus to mitigating risk for medication management
in the emergency department. Reducing opportunities for
medication error and increasing the opportunities for a safe
medication management environment represents a prime opportunity
to improve the healthcare delivery system – and helping your
organization do so is the goal of this tool.