The Script: New Year Brings Changes in Pharmacy Laws For 2019
The Script: New Year Brings Changes in Pharmacy Laws For 2019
THE SCRIPT
MARCH 2019
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2 The Script - March 2019
FAQs about complying with new rules
for security prescriptions under AB 1753
1. Previous communications an identifying number assigned found using the following link:
have indicated that there to the approved printer by the https://www.pharmacy.ca.gov/
is no transition period for Department of Justice. None publications/corresponding_
prescriptions written after of these numbers meet the responsibility.pdf.
January 1, 2019, without a requirement of the new law.
serial number. Who would The new serial number will be 4. Is the new uniquely
enforce provisions against a 15-digit alphanumeric serial serialized number required
dispensers that determine number in the following format: on e-scripts?
it is in the best interest of AAANNNNNNANNNNN.
the patient to dispense (A represents an alpha character, No, the requirement does not
a medication issued on a and N represents a numeral.) apply to e-scripts (computer
form that does not include to computer). Prescribers are
a serialized number? 3. I was presented with a encouraged to e-prescribe
controlled substance whenever possible.
The Enforcement Committee has prescription form that
recommended to the board and has a uniquely serialized 5. As a result of AB 1753,
to the executive ofcer that prior number printed on it that the information that
to July 1, 2019, the board not is consistent with the must be reported to
make an enforcement priority alphanumeric number CURES by a dispensing
any investigation or action format above, but I’m still pharmacy, clinic or other
against a pharmacist who, in the not sure the prescription dispenser was amended.
exercise of his or her professional form is compliant. Should I Health and Safety Code
judgment, determines that refuse to fll it? 11165(d)(11) states, “The
it is in the best interest of serial number for the
patient or public health or Always use your best corresponding prescription
safety to nonetheless fll such professional judgment when form, if applicable” must
prescription. flling prescriptions. However, be reported. Does “if
contacting the prescriber applicable” mean the serial
2. Many of the security to determine whether number must be reported
prescription forms printed the controlled substance only if it is present on the
prior to January 1, 2019, prescription form was printed form?
have a serialized number by an approved security printer
already printed on them. might assist you in determining No. A uniquely serialized
Are the forms compliant if if the form is legitimate. The number, in a manner prescribed
they contain a serialized approved list of security printers by the Department of Justice,
number, or is it a diferent can be found on the following must be present on all controlled
number? website: https://oag.ca.gov/ substance prescription forms.
security-printers/approved-list. “If applicable” refers to those
Prior to January 1, 2019, every exceptions in which a serial
batch of controlled substance You might also want to consider number would not be available:
prescription forms was required if any other red fags are present E-scripts, telephone or verbal
to have a lot number printed on when making your decision. prescriptions for Schedule III-V
the form, as well as a sequential The board’s corresponding
number. They also had to have responsibility brochure can be See AB 1753 FAQs, Page 6
(Chapter 589, Statutes of 2018) from being installed, leased, owned or operated
in California unless specifc requirements are met.
This law reclassifes specifc hydrocodone Additionally, drugs can be stored for a period
combination products as Schedule II controlled of up to 48 hours in a secured room within the
substances, making California law consistent with ADDS location. The bill authorizes a pharmacy
federal law. inspector employed by the board to enter the
location or proposed location of an ADDS for
AB 2789 (Wood) Health Care Practitioners:
inspection pursuant to these provisions. Lastly, this
Prescriptions: Electronic Data Transmission
bill requires the board to report to the Legislature
(Chapter 438, Statutes of 2018) regarding the regulations of ADDS machines on
or before January 1, 2024, as part of the board’s
This law requires that all written prescriptions sunset evaluation process.
issued by licensed prescribers in California be
issued as electronic transmission prescriptions – AB 2138 (Chiu/Low) Licensing Boards: Denial
also known as e-prescriptions – by Jan. 1, 2022. of Application: Revocation or Suspension of
In addition, all pharmacies, pharmacists or other Licensure: Criminal Conviction
practitioners authorized to dispense or furnish
(Chapter 995, Statues of 2018)
a medication must have the ability to receive
e-prescriptions by Jan. 1, 2022. The law includes Efective July 1, 2020, this law places restrictions on
multiple exemptions. convictions, crime and other acts that the Board
of Pharmacy may consider in denying, revoking
SB 1447 (Hernandez) Pharmacy: Automated
or suspending a license. The law also requires the
Drug Delivery Systems
board to report denial summaries on its website; in
(Chapter 666, Statutes of 2018) addition, the website must include a list of crimes
that will be considered for denial and how those
AB 2037 (Bonta) Pharmacy: Automated Patient crimes substantially relate to the qualifcations,
Dispensing Systems functions or duties of the practice of pharmacy.
(Chapter 647, Statutes of 2018) AB 2859 (Caballero) Pharmacy: Safe Storage
Products
SB 1447 and AB 2037 establish requirements
for automated drug delivery system (ADDS) (Chapter 240, Statutes of 2018)
registration requirements with a licensing program
that recognizes the diferent uses for such a device. This law requires community pharmacies that
The measures establish defnitions for two diferent dispense Schedule II, III or IV controlled substances
types of ADDS devices: to display safe storage products on the premises
and close to the pharmacy. Pharmacies where a
• An automated unit dose system (AUDS) licensed pharmacist is the majority owner and
is an ADDS for storage and retrieval of manager of no more than four pharmacies are
unit doses of drugs for administration to exempt from this law. This law will remain in efect
patients by authorized persons. until Jan. 1, 2023.
• An automated patient dispensing system SB 212 (Jackson) Solid Waste: Pharmaceutical
(APDS) is an ADDS for storage and and Sharps Waste Stewardship
dispensing of prescribed drugs directly to
patients. (Chapter 1004, Statutes of 2018)
Efective July 1, 2019, SB 1447 prohibits an ADDS See New laws, Page 5
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4 The Script - March 2019
New laws
Continued from page 4
This law establishes a stewardship program to that another employee of either the pharmacy or
fund drug take-back programs and sharps disposal the establishment be made available to assist the
programs throughout California. Funding is to pharmacist at all times. The law provides some
be provided by covered entities (typically drug exceptions.
manufacturers or distributors). The law requires
CalRecycle to develop regulations governing the Laws related to health care coverage and
stewardship program by no later than Jan. 1, 2021. prescription drugs:
The law also requires the Board of Pharmacy to
AB 2863 (Nazarian) Health Care Coverage:
develop and maintain a list of all covered drugs
Prescriptions
sold in California. In addition, the board is required
to review each stewardship plan for compliance (Chapter 770, Statutes of 2018)
with federal and state laws governing drug take-
back programs. This law requires a pharmacy to inform the
consumer of the lower price of a covered
SB 1109 (Bates) Controlled Substances: medication – whether it is the retail price or the
Schedule II Drugs: Opioids cost-sharing amount – unless the pharmacy
automatically charges the lower amount. The
(Chapter 693, Statutes of 2018)
pharmacy must submit the retail cost to the health
This law requires prescribers to complete care plan in the same manner as if the customer
continuing education on the hazards of opioid use. had paid the copay amount.
The law also requires a specifed warning notice be
AB 315 (Wood) Pharmacy Beneft Management
prominently displayed on the label or container of
an opioid dispense to a patient for outpatient use. (Chapter 905, Statutes of 2018)
SB 1254 (Stone) Hospital Pharmacies: This law requires a pharmacy to inform the
Medication Profles or Lists for High-Risk customer at the point of sale whether the retail
Patients price of a covered prescription drug is lower
than the copay amount, unless the pharmacy
(Chapter 697, Statutes of 2018)
automatically charges the lower amount. The
This law requires a pharmacist at a hospital pharmacy must submit the retail cost to the health
pharmacy to obtain an accurate medication profle care plan in the same manner as if the customer
or list for each high-risk patient upon admission had paid the copay amount.
or discharge. Each hospital will establish criteria
SB 1021 (Wiener) Prescription Drugs
for determining whether a patient is high-risk.
The law allows for a pharmacy technician or intern (Chapter 787, Statutes of 2018)
pharmacist to perform the task if he or she has
successfully completed training and proctoring by This law extends provisions regarding drug
the pharmacy department or another healing arts formulary coverage. It requires a drug beneft plan
licensee issued a licensed pursuant to Division 2. to provide that if the pharmacy’s retail price for a
The board has authority to adopt regulations. prescription drug is less than the applicable copay
amount, the consumer shall not be required to pay
SB 1442 (Wiener) Community Pharmacies: more than the retail price.
Stafng
(Chapter 569, Statutes of 2018)
This law prohibits a community pharmacy from
requiring a pharmacist to work alone. It requires
controlled substances, faxed serialized number is not one of Only controlled substance
prescriptions, or prescriptions the elements of the form that is prescription forms written on
dispensed pursuant to HSC exempt under this section. or after January 1, 2019, must
sections 11159.2, 11167 or have the new serialized number
11167.5. 9. Providers have been asking printed on the controlled
me where they should substance prescription form.
6. Will the new controlled go to get new controlled
substance prescription substance prescription 12. How do we report the
forms have the new forms with the new new serialized number to
uniquely serialized serialized numbers. Where CURES?
number as well as all the can I direct them?
other numbers that were You should contact your
previously required (lot The approved list of security computer software vendor.
number, sequential number printers can be found on the You will need to ensure your
and number assigned to following website: https:// system has a way to transmit the
the security printer)? oag.ca.gov/security-printers/ 15-digit serialized number to
approved-list. CURES.
Yes.
10. If a controlled substance 13. If, based on my best
7. Can prescriptions for prescription was written judgment, I decide to fll
Schedule III through V in 2018 and has all the a controlled substance
controlled substances still elements of a compliant prescription that is
be phoned in or faxed to a prescription form, except compliant in ALL ways with
pharmacy? the new serialized number, the exception of the new
is it considered compliant? serialized number, will I get
Yes. There have been no legal in trouble with the DEA?
changes to the ability to phone Yes. Only controlled substance
in or fax prescriptions for prescriptions written on or after The change is in the California
Schedule III through V controlled January 1, 2019, must have the Health and Safety Code,
substances new serialized number printed not federal law. It is our
on the controlled substance understanding that the DEA
8. We print on controlled prescription form. Keep in mind enforces only federal law.
substances prescription that a controlled substances
forms from the emergency prescription may only be flled
department at our hospital within the frst six months of
pursuant to HSC 11162(c). issuance.
Do we create our own
serialized number? How do 11. If a Schedule III-V
we get serialized numbers controlled substances
on the secure paper? prescription with reflls was
initially flled in 2018, can
Your hospital must order it be reflled after January
new controlled substances 1, 2019, or do we need to
prescription forms for use by get a new prescription that
prescribers when treating contains the new serialized
patients in your facility. The number?
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6 The Script - March 2019
SB 1109 requires warning AB 1753
Continued from page 2
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8 The Script - March 2019
Pharmacists must sign, receive drugs
delivered to pharmacy by wholesaler
and received by a pharmacist.” (Emphasis added.)
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10 The Script - March 2019
Board policy supports hazard labels
on oral chemotherapy medications
The Board of Pharmacy encourages pharmacists provide specifc counseling to patients and their
to educate their patients about proper handling caregivers on proper handling and disposal of
and disposal of oral chemotherapy medications. oral chemotherapy medications.
At a meeting January 30, 2019, the board adopted
the following policy statement encouraging To help patients, caregivers and health care
pharmacists to afx a warning symbol to providers recognize these medications as
prescription labels for oral chemotherapy hazardous, the board encourages pharmacies
medications: to afx a standardized “hazardous drug” symbol
to prescription labels when appropriate. The
The California State Board of Pharmacy recognizes addition of the symbol would serve as an
that oral chemotherapy treatment is increasingly important reminder to patients and caregivers
common among cancer patients and health about the proper handling and disposal of the
care providers. However, these medications pose drugs.
serious risks to humans and the environment if
improperly handled or disposed of. Many patients, The following represents an appropriate warning
caregivers and even health care providers may symbol:
not recognize these drugs or be aware of their
hazardous nature.
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reduced a pregnant women’s risk of hospitalization
by an average of 40%.
www.pharmacy.ca.gov
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12 The Script - March 2019
New Compounding Committee meets,
hears about proposed changes to USP
policy issues Scheduled meetings in 2019 are:
for the board • March 13
related to drug • April 16
compounding, • June 4
including • July 1
the impact • Aug. 28
of proposed • Sept. 24
revisions to • Oct. 16
USP chapters.
Information about
The Compounding Committee
The Compounding Committee holds its frst meeting Compounding meetings can be found online
in Sacramento. Committee’s under “Board and Committee
frst four Meetings” at the Board of
The Board of Pharmacy’s
meetings are intended for staf Pharmacy website. People
newly created Compounding
to educate the committee interested in attending are
Committee held its frst meeting
members about proposed encouraged to review relevant
Feb. 20, 2019, in Sacramento.
changes to USP. The committee USP chapters at the USP website,
Formerly part of the Enforcement
then will consider what, if any, http://www.usp.org/, before the
and Compounding Committee,
changes should be made to committee meetings.
the new committee was
California pharmacy law.
established to focus on major