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(3) “Entity” means an organization that operates, or provides or
makes available, a health information technology system to a
health care practitioner or pharmacist.
(4) “Health information technology system” means an
information processing application using hardware and software
for the storage, retrieval, sharing of or use of patient data for
communication, decision-making, coordination of care, or the
quality, safety, or efficiency of the practice of medicine or
delivery of health care services, including, but not limited to,
electronic medical record applications, health information
exchange systems, or other interoperable clinical or health care
information system.
(h) This section shall become operative on July 1, 2021, or upon
the date the department promulgates regulations to implement
this section and posts those regulations on its internet website,
whichever date is earlier.
11165.2. CURES Violation: Citations; Request for Hearing; Fines
(a) The Department of Justice may conduct audits of the CURES
Prescription Drug Monitoring Program system and its users.
(b) The Department of Justice may establish, by regulation, a
system for the issuance to a CURES Prescription Drug Monitoring
Program subscriber of a citation which may contain an order of
abatement, or an order to pay an administrative fine assessed by
the Department of Justice if the subscriber is in violation of any
provision of this chapter or any regulation adopted by the
Department of Justice pursuant to this chapter.
(c) The system shall contain the following provisions:
(1) Citations shall be in writing and shall describe with
particularity the nature of the violation, including specific
reference to the provision of law or regulation of the department
determined to have been violated.
(2) Whenever appropriate, the citation shall contain an order of
abatement establishing a reasonable time for abatement of the
violation.
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(3) In no event shall the administrative fine assessed by the
department exceed two thousand five hundred dollars ($2,500)
for each violation. In assessing a fine, due consideration shall be
given to the appropriateness of the amount of the fine with
respect to such factors as the gravity of the violation, the good
faith of the subscribers, and the history of previous violations.
(4) An order of abatement or a fine assessment issued pursuant
to a citation shall inform the subscriber that if the subscriber
desires a hearing to contest the finding of a violation, a hearing
shall be requested by written notice to the CURES Prescription
Drug Monitoring Program within 30 days of the date of issuance
of the citation or assessment. Hearings shall be held pursuant to
Chapter 5 (commencing with Section 11500) of Part 1 of Division
3 of Title 2 of the Government Code.
(5) In addition to requesting a hearing, the subscriber may,
within 10 days after service of the citation, request in writing an
opportunity for an informal conference with the department
regarding the citation. At the conclusion of the informal
conference, the department may affirm, modify, or dismiss the
citation, including any fine levied or order of abatement issued.
The decision shall be deemed to be a final order with regard to
the citation issued, including the fine levied or the order of
abatement which could include permanent suspension to the
system, a monetary fine, or both, depending on the gravity of the
violation. However, the subscriber does not waive its right to
request a hearing to contest a citation by requesting an informal
conference. If the citation is affirmed, a formal hearing may be
requested within 30 days of the date the citation was affirmed. If
the citation is dismissed after the informal conference, the
request for a hearing on the matter of the citation shall be
deemed to be withdrawn. If the citation, including any fine levied
or order of abatement, is modified, the citation originally issued
shall be considered withdrawn and a new citation issued. If a
hearing is requested for a subsequent citation, it shall be
requested within 30 days of service of that subsequent citation.
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(6) Failure of a subscriber to pay a fine within 30 days of the
date of assessment or comply with an order of abatement within
the fixed time, unless the citation is being appealed, may result in
disciplinary action taken by the department. If a citation is not
contested and a fine is not paid, the subscriber account will be
terminated:
(A) A citation may be issued without the assessment of an
administrative fine.
(B) Assessment of administrative fines may be limited to only
particular violations of law or department regulations.
(d) Notwithstanding any other provision of law, if a fine is paid
to satisfy an assessment based on the finding of a violation,
payment of the fine shall be represented as a satisfactory
resolution of the matter for purposes of public disclosure.
(e) Administrative fines collected pursuant to this section shall
be deposited in the CURES Program Special Fund, available upon
appropriation by the Legislature. These special funds shall
provide support for costs associated with informal and formal
hearings, maintenance, and updates to the CURES Prescription
Drug Monitoring Program.
(f) The sanctions authorized under this section shall be separate
from, and in addition to, any other administrative, civil, or
criminal remedies; however, a criminal action may not be
initiated for a specific offense if a citation has been issued
pursuant to this section for that offense, and a citation may not
be issued pursuant to this section for a specific offense if a
criminal action for that offense has been filed.
(g) Nothing in this section shall be deemed to prevent the
department from serving and prosecuting an accusation to
suspend or revoke a subscriber if grounds for that suspension or
revocation exist.
11165.3. Report Theft/Loss of Security Forms
The theft or loss of prescription forms shall be reported
immediately by the security printer or affected prescriber to the
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CURES Prescription Drug Monitoring Program, but no later than
three days after the discovery of the theft or loss. This
notification may be done in writing utilizing the approved
Department of Justice form or may be reported by the
authorized subscriber through the CURES Prescription Drug
Monitoring Program.
11165.4. CURES; Prescribers’ Duty Required to Consult
(a) (1) (A) (i) A health care practitioner authorized to prescribe,
order, administer, or furnish a controlled substance shall consult
the patient activity report or information from the patient
activity report obtained from the CURES database to review a
patient’s controlled substance history for the past 12 months
before prescribing a Schedule II, Schedule III, or Schedule IV
controlled substance to the patient for the first time and at least
once every six months thereafter if the prescriber renews the
prescription and the substance remains part of the treatment of
the patient.
(ii) If a health care practitioner authorized to prescribe, order,
administer, or furnish a controlled substance is not required,
pursuant to an exemption described in subdivision (c), to consult
the patient activity report from the CURES database the first time
the health care practitioner prescribes, orders, administers, or
furnishes a controlled substance to a patient, the health care
practitioner shall consult the patient activity report from the
CURES database to review the patient’s controlled substance
history before subsequently prescribing a Schedule II, Schedule
III, or Schedule IV controlled substance to the patient and at least
once every six months thereafter if the prescriber renews the
prescription and the substance remains part of the treatment of
the patient.
(iii) A health care practitioner who did not directly access the
CURES database to perform the required review of the controlled
substance use report shall document in the patient’s medical
record that they reviewed the CURES database generated report
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within 24 hours of the controlled substance prescription that was
provided to them by another authorized user of the CURES
database.
(B) For purposes of this paragraph, “first time” means the initial
occurrence in which a health care practitioner, in their role as a
health care practitioner, intends to prescribe, order, administer,
or furnish a Schedule II, Schedule III, or Schedule IV controlled
substance to a patient and has not previously prescribed a
controlled substance to the patient.
(2) A health care practitioner shall review a patient’s controlled
substance history that has been obtained from the CURES
database no earlier than 24 hours, or the previous business day,
before the health care practitioner prescribes, orders,
administers, or furnishes a Schedule II, Schedule III, or Schedule
IV controlled substance to the patient.
(b) The duty to consult the CURES database, as described in
subdivision (a), does not apply to veterinarians or pharmacists.
(c) The duty to consult the CURES database, as described in
subdivision (a), does not apply to a health care practitioner in any
of the following circumstances:
(1) If a health care practitioner prescribes, orders, or furnishes a
controlled substance to be administered to a patient in any of the
following facilities or during a transfer between any of the
following facilities, or for use while on facility premises:
(A) A licensed clinic, as described in Chapter 1 (commencing
with Section 1200) of Division 2.
(B) An outpatient setting, as described in Chapter 1.3
(commencing with Section 1248) of Division 2.
(C) A health facility, as described in Chapter 2 (commencing with
Section 1250) of Division 2.
(D) A county medical facility, as described in Chapter 2.5
(commencing with Section 1440) of Division 2.
(E) Another medical facility, including, but not limited to, an
office of a health care practitioner and an imaging center.
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(F) A correctional clinic, as described in Section 4187 of the
Business and Professions Code, or a correctional pharmacy, as
described in Section 4021.5 of the Business and Professions
Code.
(2) If a health care practitioner prescribes, orders, administers,
or furnishes a controlled substance in the emergency department
of a general acute care hospital and the quantity of the
controlled substance does not exceed a nonrefillable seven-day
supply of the controlled substance to be used in accordance with
the directions for use.
(3) If a health care practitioner prescribes, orders, administers,
or furnishes a controlled substance to a patient as part of the
patient’s treatment for a surgical, radiotherapeutic, therapeutic,
or diagnostic procedure and the quantity of the controlled
substance does not exceed a nonrefillable seven-day supply of
the controlled substance to be used in accordance with the
directions for use, in any of the following facilities:
(A) A licensed clinic, as described in Chapter 1 (commencing
with Section 1200) of Division 2.
(B) An outpatient setting, as described in Chapter 1.3
(commencing with Section 1248) of Division 2.
(C) A health facility, as described in Chapter 2 (commencing with
Section 1250) of Division 2.
(D) A county medical facility, as described in Chapter 2.5
(commencing with Section 1440) of Division 2.
(E) A place of practice, as defined in Section 1658 of the
Business and Professions Code.
(F) Another medical facility where surgical procedures are
permitted to take place, including, but not limited to, the office
of a health care practitioner.
(4) If a health care practitioner prescribes, orders, administers,
or furnishes a controlled substance to a patient who is terminally
ill, as defined in subdivision (c) of Section 11159.2.
(5) (A) If all of the following circumstances are satisfied:
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(i) It is not reasonably possible for a health care practitioner to
access the information in the CURES database in a timely
manner.
(ii) Another health care practitioner or designee authorized to
access the CURES database is not reasonably available.
(iii) The quantity of controlled substance prescribed, ordered,
administered, or furnished does not exceed a nonrefillable seven-
day supply of the controlled substance to be used in accordance
with the directions for use and no refill of the controlled
substance is allowed.
(B) A health care practitioner who does not consult the CURES
database under subparagraph (A) shall document the reason
they did not consult the database in the patient’s medical record.
(6) If the CURES database is not operational, as determined by
the department, or cannot be accessed by a health care
practitioner because of a temporary technological or electrical
failure. A health care practitioner shall, without undue delay,
seek to correct the cause of the temporary technological or
electrical failure that is reasonably within the health care
practitioner’s control.
(7) If the CURES database cannot be accessed because of
technological limitations that are not reasonably within the
control of a health care practitioner.
(8) If consultation of the CURES database would, as determined
by the health care practitioner, result in a patient’s inability to
obtain a prescription in a timely manner and thereby adversely
impact the patient’s medical condition, provided that the
quantity of the controlled substance does not exceed a
nonrefillable seven-day supply if the controlled substance were
used in accordance with the directions for use.
(d) (1) A health care practitioner who fails to consult the CURES
database, as described in subdivision (a), shall be referred to the
appropriate state professional licensing board solely for
administrative sanctions, as deemed appropriate by that board.
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(2) This section does not create a private cause of action against
a health care practitioner. This section does not limit a health
care practitioner’s liability for the negligent failure to diagnose or
treat a patient.
(e) All applicable state and federal privacy laws govern the
duties required by this section.
(f) The provisions of this section are severable. If any provision
of this section or its application is held invalid, that invalidity shall
not affect other provisions or applications that can be given
effect without the invalid provision or application.
(g) This section shall become operative on July 1, 2021, or upon
the date the department promulgates regulations to implement
this section and posts those regulations on its internet website,
whichever date is earlier.
11165.5. CURES Funding; Definitions
(a) The Department of Justice may seek voluntarily contributed
private funds from insurers, health care service plans, qualified
manufacturers, and other donors for the purpose of supporting
CURES. Insurers, health care service plans, qualified
manufacturers, and other donors may contribute by submitting
their payment to the Controller for deposit into the CURES Fund
established pursuant to subdivision (c) of Section 208 of the
Business and Professions Code. The department shall make
information about the amount and the source of all private funds
it receives for support of CURES available to the public.
Contributions to the CURES Fund pursuant to this subdivision
shall be nondeductible for state tax purposes.
(b) For purposes of this section, the following definitions apply:
(1) “Controlled substance” means a drug, substance, or
immediate precursor listed in any schedule in Section 11055,
11056, or 11057 of the Health and Safety Code.
(2) “Health care service plan” means an entity licensed pursuant
to the Knox-Keene Health Care Service Plan Act of 1975 (Chapter
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2.2 (commencing with Section 1340) of Division 2 of the Health
and Safety Code).
(3) “Insurer” means an admitted insurer writing health
insurance, as defined in Section 106 of the Insurance Code, and
an admitted insurer writing workers’ compensation insurance, as
defined in Section 109 of the Insurance Code.
(4) “Qualified manufacturer” means a manufacturer of a
controlled substance, but does not mean a wholesaler or
nonresident wholesaler of dangerous drugs, regulated pursuant
to Article 11 (commencing with Section 4160) of Chapter 9 of
Division 2 of the Business and Professions Code, a veterinary
food-animal drug retailer, regulated pursuant to Article 15
(commencing with Section 4196) of Chapter 9 of Division 2 of the
Business and Professions Code, or an individual regulated by the
Medical Board of California, the Dental Board of California, the
California State Board of Pharmacy, the Veterinary Medical
Board, the Board of Registered Nursing, the Physician Assistant
Committee of the Medical Board of California, the Osteopathic
Medical Board of California, the State Board of Optometry, or the
California Board of Podiatric Medicine.
11165.6. Prescriber Access for List of Prescriber’s Patients
A prescriber shall be allowed to access the CURES database for a
list of patients for whom that prescriber is listed as a prescriber in
the CURES database.
11166. Time Limit for Filling a Controlled Substance
Prescription; Knowingly Filling Mutilated, Forged, or Altered
Prescription Prohibited
No person shall fill a prescription for a controlled substance
after six months has elapsed from the date written on the
prescription by the prescriber. No person shall knowingly fill a
mutilated or forged or altered prescription for a controlled
substance except for the addition of the address of the person
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for whom the controlled substance is prescribed as provided by
paragraph (3) of subdivision (b) of Section 11164.
11167. Emergency Dispensing of Controlled Substance;
Circumstances and Requirements
Notwithstanding subdivision (a) of Section 11164, in an
emergency where failure to issue a prescription may result in loss
of life or intense suffering, an order for a controlled substance
may be dispensed on an oral order, an electronic data
transmission order, or a written order not made on a controlled
substance form as specified in Section 11162.1, subject to all of
the following requirements:
(a) The order contains all information required by subdivision (a)
of Section 11164.
(b) Any written order is signed and dated by the prescriber in
ink, and the pharmacy reduces any oral or electronic data
transmission order to hard copy form prior to dispensing the
controlled substance.
(c) The prescriber provides a written prescription on a
controlled substance prescription form that meets the
requirements of Section 11162.1, by the seventh day following
the transmission of the initial order; a postmark by the seventh
day following transmission of the initial order shall constitute
compliance.
(d) If the prescriber fails to comply with subdivision (c), the
pharmacy shall so notify the Bureau of Narcotic Enforcement in
writing within 144 hours of the prescriber's failure to do so and
shall make and retain a hard copy, readily retrievable record of
the prescription, including the date and method of notification of
the Bureau of Narcotic Enforcement.
(e) This section shall become operative on January 1, 2005.
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11167.5. Oral or Electronic Prescriptions for Schedule II
Controlled Substance for Specified Inpatients, Residents, and
Home Hospice Patients; Requirements
(a) An order for a controlled substance classified in Schedule II
for a patient of a licensed skilled nursing facility, a licensed
intermediate care facility, a licensed home health agency, or a
licensed hospice may be dispensed upon an oral or electronically
transmitted prescription. If the prescription is transmitted orally,
the pharmacist shall, prior to filling the prescription, reduce the
prescription to writing in ink in the handwriting of the pharmacist
on a form developed by the pharmacy for this purpose. If the
prescription is transmitted electronically, the pharmacist shall,
prior to filling the prescription, produce, sign, and date a hard
copy prescription. The prescriptions shall contain the date the
prescription was orally or electronically transmitted by the
prescriber, the name of the person for whom the prescription
was authorized, the name and address of the licensed skilled
nursing facility, licensed intermediate care facility, licensed home
health agency, or licensed hospice in which that person is a
patient, the name and quantity of the controlled substance
prescribed, the directions for use, and the name, address,
category of professional licensure, license number, and federal
controlled substance registration number of the prescriber. The
original shall be properly endorsed by the pharmacist with the
pharmacy's state license number, the name and address of the
pharmacy, and the signature of the person who received the
controlled substances for the licensed skilled nursing facility,
licensed intermediate care facility, licensed home health agency,
or licensed hospice. A licensed skilled nursing facility, a licensed
intermediate care facility, a licensed home health agency, or a
licensed hospice shall forward to the dispensing pharmacist a
copy of any signed telephone orders, chart orders, or related
documentation substantiating each oral or electronically
transmitted prescription transaction under this section.
(b) This section shall become operative on January 1, 2005.
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11170. Prohibition on Prescribing, etc. Controlled Substance for
Self
No person shall prescribe, administer, or furnish a controlled
substance for himself.
11171. Prescribing, etc. Controlled Substance Only as
Authorized
No person shall prescribe, administer, or furnish a controlled
substance except under the conditions and in the manner
provided by this division.
11172. Antedating or Postdating Prescription Prohibited
No person shall antedate or postdate a prescription.
11173. Fraud, Deceit, Misrepresentation or False Statement;
False Representation; False Label
(a) No person shall obtain or attempt to obtain controlled
substances, or procure or attempt to procure the administration
of or prescription for controlled substances, (1) by fraud, deceit,
misrepresentation , or subterfuge; or (2) by the concealment of a
material fact.
(b) No person shall make a false statement in any prescription,
order, report, or record, required by this division.
(c) No person shall, for the purpose of obtaining controlled
substances, falsely assume the title of, or represent himself to be,
a manufacturer, wholesaler, pharmacist, physician, dentist,
veterinarian, registered nurse, physician's assistant, or other
authorized person.
(d) No person shall affix any false or forged label to a package or
receptacle containing controlled substances.
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11174. Prohibition on Providing False Name or Address in
Connection with Prescription, etc.
No person shall, in connection with the prescribing, furnishing,
administering, or dispensing of a controlled substance, give a
false name or false address.
11175. Prohibition on Obtaining or Possessing Nonconforming
Prescription; Prohibition on Obtaining Controlled Substance by
Nonconforming Prescription
No person shall obtain or possess a prescription that does not
comply with this division, nor shall any person obtain a controlled
substance by means of a prescription which does not comply
with this division or possess a controlled substance obtained by
such a prescription.
11179. Retention of Controlled Substance Prescription
A person who fills a prescription shall keep it on file for at least
three years from the date of filling it.
11180. Prohibition of Controlled Substance Obtained or
Possessed by Nonconforming Prescription
No person shall obtain or possess a controlled substance
obtained by a prescription that does not comply with this
division.
Article 2. Prescriber’s Record
11190. Prescriber’s Record for Schedule II. III or IV Controlled
Substance; Prescription Requirements
(a) Every practitioner, other than a pharmacist, who prescribes
or administers a controlled substance classified in Schedule II
shall make a record that, as to the transaction, shows all of the
following:
(1) The name and address of the patient.
(2) The date.
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(3) The character, including the name and strength, and
quantity of controlled substances involved.
(b) The prescriber's record shall show the pathology and
purpose for which the controlled substance was administered or
prescribed.
(c) (1) For each prescription for a Schedule II, Schedule III, or
Schedule IV controlled substance that is dispensed by a
prescriber pursuant to Section 4170 of the Business and
Professions Code, the prescriber shall record and maintain the
following information:
(A) Full name, address, and the telephone number of the
ultimate user or research subject, or contact information as
determined by the Secretary of the United States Department of
Health and Human Services, and the gender, and date of birth of
the patient.
(B) The prescriber's category of licensure and license number;
federal controlled substance registration number; and the state
medical license number of any prescriber using the federal
controlled substance registration number of a government-
exempt facility.
(C) NDC (National Drug Code) number of the controlled
substance dispensed.
(D) Quantity of the controlled substance dispensed.
(E) ICD-9 (diagnosis code), if available.
(F) Number of refills ordered.
(G) Whether the drug was dispensed as a refill of a prescription
or as a first-time request.
(H) Date of origin of the prescription.
(2) (A) Each prescriber that dispenses controlled substances
shall provide the Department of Justice the information required
by this subdivision on a weekly basis in a format set by the
Department of Justice pursuant to regulation.
(B) The reporting requirement in this section shall not apply to
the direct administration of a controlled substance to the body of
an ultimate user.
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(d) This section shall become operative on January 1, 2005.
(e) The reporting requirement in this section for Schedule IV
controlled substances shall not apply to any of the following:
(1) The dispensing of a controlled substance in a quantity
limited to an amount adequate to treat the ultimate user
involved for 48 hours or less.
(2) The administration or dispensing of a controlled substance in
accordance with any other exclusion identified by the United
States Health and Human Service Secretary for the National All
Schedules Prescription Electronic Reporting Act of 2005.
(f) Notwithstanding paragraph (2) of subdivision (c), the
reporting requirement of the information required by this section
for a Schedule II or Schedule III controlled substance, in a format
set by the Department of Justice pursuant to regulation, shall be
on a monthly basis for all of the following:
(1) The dispensing of a controlled substance in a quantity
limited to an amount adequate to treat the ultimate user
involved for 48 hours or less.
(2) The administration or dispensing of a controlled substance in
accordance with any other exclusion identified by the United
States Health and Human Service Secretary for the National All
Schedules Prescription Electronic Reporting Act of 2005.
11191. Retention Period; Violation
The record shall be preserved for three years. Every person who
violates any provision of this section is guilty of a misdemeanor.
11192. Prima Facie Evidence of Violation of Section 11190
In a prosecution for a violation of Section 11190, proof that a
defendant received or has had in his possession at any time a
greater amount of controlled substances than is accounted for by
any record required by law or that the amount of controlled
substances possessed by a defendant is a lesser amount than is
accounted for by any record required by law is prima facie
evidence of a violation of the section.
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Article 3. Copies of Prescriptions
11195. Providing Receipt for Prescription Removed by Peace
Officer, Board Inspector, etc.
Whenever the pharmacist's copy of a controlled substance
prescription is removed by a peace officer, agent of the Attorney
General, or inspector of the Board of Pharmacy, or investigator of
the Division of Investigation of the Department of Consumer
Affairs for the purpose of investigation or as evidence, the officer
or inspector or investigator shall give to the pharmacist a receipt
in lieu thereof.
Article 4. Refilling Prescriptions
11200. Restrictions on Dispensing or Refilling; Refill of Schedule
II Prescription Prohibited
(a) No person shall dispense or refill a controlled substance
prescription more than six months after the date thereof.
(b) No prescription for a Schedule III or IV substance may be
refilled more than five times and in an amount, for all refills of
that prescription taken together, exceeding a 120-day supply.
(c) No prescription for a Schedule II substance may be refilled.
11201. Emergency Refill of Schedule III, IV, or V Prescription;
Circumstances; Requirements
A prescription for a controlled substance, except those
appearing in schedule II, may be refilled without the prescriber's
authorization if the prescriber is unavailable to authorize the
refill and if, in the pharmacist's professional judgment, failure to
refill the prescription might present an immediate hazard to the
patient's health and welfare or might result in intense suffering.
The pharmacist shall refill only a reasonable amount sufficient to
maintain the patient until the prescriber can be contacted. The
pharmacist shall note on the reverse side of the prescription the
date and quantity of the refill and that the prescriber was not
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available and the basis for his judgment to refill the prescription
without the prescriber's authorization. The pharmacist shall
inform the patient that the prescription was refilled without the
prescriber's authorization, indicating that the prescriber was not
available and that, in the pharmacist's professional judgment,
failure to provide the drug might result in an immediate hazard
to the patient's health and welfare or might result in intense
suffering. The pharmacist shall inform the prescriber within a
reasonable period of time. Prior to refilling a prescription
pursuant to this section, the pharmacist shall make every
reasonable effort to contact the prescriber.
The prescriber shall not incur any liability as the result of a
refilling of a prescription pursuant to this section.
Article 5. Pharmacists’ Records
11205. Maintenance and Retention of Records in Separate File
The owner of a pharmacy or any person who purchases a
controlled substance upon federal order forms as required
pursuant to the provisions of the Federal "Comprehensive Drug
Abuse Prevention and Control Act of 1970," (P.L. 91-513, 84 Stat.
1236), relating to the importation, exportation, manufacture,
production, compounding, distribution, dispensing, and control
of controlled substances, and who sells controlled substances
obtained upon such federal order forms in response to
prescriptions shall maintain and file such prescriptions in a
separate file apart from noncontrolled substances prescriptions.
Such files shall be preserved for a period of three years.
11206. Required Information on Prescription
Filed prescriptions shall constitute a transaction record that,
together with information that is readily retrievable in the
pharmacy pursuant to Section 11164 shall show or include the
following:
(a) The name(s) and address of the patient(s).
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(b) The date.
(c) The character, including the name and strength, quantity,
and directions for use of the controlled substance involved.
(d) The name, address, telephone number, category of
professional licensure, and the federal controlled substance
registration number of the prescriber.
11207. Only Pharmacist or Intern Authorized to Fill Prescription
(a) No person other than a pharmacist as defined in Section
4036 of the Business and Professions Code or an intern
pharmacist, as defined in Section 4030 of the Business and
Professions Code, who is under the personal supervision of a
pharmacist, shall compound, prepare, fill or dispense a
prescription for a controlled substance.
(b) Notwithstanding subdivision (a), a pharmacy technician may
perform those tasks permitted by Section 4115 of the Business
and Professions Code when assisting a pharmacist dispensing a
prescription for a controlled substance.
11208. Prima Facie Evidence of Violation of Controlled
Substance Act
In a prosecution under this division, proof that a defendant
received or has had in his possession at any time a greater
amount of controlled substances than is accounted for by any
record required by law or that the amount of controlled
substances possessed by the defendant is a lesser amount than is
accounted for by any record required by law is prima facie
evidence of guilt.
11209. Delivery and Receiving Requirements for Schedule II, III,
and IV Substances; Violation
(a) No person shall deliver Schedule II, III, or IV controlled
substances to a pharmacy or pharmacy receiving area, nor shall
any person receive controlled substances on behalf of a
pharmacy unless, at the time of delivery, a pharmacist or
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authorized receiving personnel signs a receipt showing the type
and quantity of the controlled substances received. Any
discrepancy between the receipt and the type or quantity of
controlled substances actually received shall be reported to the
delivering wholesaler or manufacturer by the next business day
after delivery to the pharmacy.
(b) The delivery receipt and any record of discrepancy shall be
maintained by the wholesaler or manufacturer for a period of
three years.
(c) A violation of this section is a misdemeanor.
(d) Nothing in this section shall require a common carrier to
label a package containing controlled substances in a manner
contrary to federal law or regulation.
CHAPTER 5. USE OF CONTROLLED SUBSTANCES
Article 1. Lawful Medical Use Other Than
Treatment of Addicts
11210. Issuing Prescription: By Whom; For What Purpose;
Quantity to Be Prescribed
A physician, surgeon, dentist, veterinarian, naturopathic doctor
acting pursuant to Section 3640.7 of the Business and Professions
Code, or podiatrist, or pharmacist acting within the scope of a
project authorized under Article 1 (commencing with Section
128125) of Chapter 3 of Part 3 of Division 107 or within the scope
of Section 4052.1, 4052.2, or 4052.6 of the Business and
Professions Code, or registered nurse acting within the scope of a
project authorized under Article 1 (commencing with Section
128125) of Chapter 3 of Part 3 of Division 107, or physician
assistant acting within the scope of a project authorized under
Article 1 (commencing with Section 128125) of Chapter 3 of Part
3 of Division 107, or naturopathic doctor acting within the scope
of Section 3640.5 of the Business and Professions Code, or an
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optometrist acting within the scope of Section 3041 of the
Business and Professions Code may prescribe for, furnish to, or
administer controlled substances to his or her patient when the
patient is suffering from a disease, ailment, injury, or infirmities
attendant upon old age, other than addiction to a controlled
substance.
The physician, surgeon, dentist, veterinarian, naturopathic
doctor acting pursuant to Section 3640.7 of the Business and
Professions Code, or podiatrist, or pharmacist acting within the
scope of a project authorized under Article 1 (commencing with
Section 128125) of Chapter 3 of Part 3 of Division 107 or within
the scope of Section 4052.1, 4052.2, or 4052.6 of the Business
and Professions Code, or registered nurse acting within the scope
of a project authorized under Article 1 (commencing with Section
128125) of Chapter 3 of Part 3 of Division 107, or physician
assistant acting within the scope of a project authorized under
Article 1 (commencing with Section 128125) of Chapter 3 of Part
3 of Division 107, or naturopathic doctor acting within the scope
of Section 3640.5 of the Business and Professions Code, or an
optometrist acting within the scope of Section 3041 of the
Business and Professions Code shall prescribe, furnish, or
administer controlled substances only when in good faith he or
she believes the disease, ailment, injury, or infirmity requires the
treatment.
The physician, surgeon, dentist, veterinarian, or naturopathic
doctor acting pursuant to Section 3640.7 of the Business and
Professions Code, or podiatrist, or pharmacist acting within the
scope of a project authorized under Article 1 (commencing with
Section 128125) of Chapter 3 of Part 3 of Division 107 or within
the scope of Section 4052.1, 4052.2, or 4052.6 of the Business
and Professions Code, or registered nurse acting within the scope
of a project authorized under Article 1 (commencing with Section
128125) of Chapter 3 of Part 3 of Division 107, or physician
assistant acting within the scope of a project authorized under
Article 1 (commencing with Section 128125) of Chapter 3 of Part
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3 of Division 107, or a naturopathic doctor acting within the
scope of Section 3640.5 of the Business and Professions Code, or
an optometrist acting within the scope of Section 3041 of the
Business and Professions Code shall prescribe, furnish, or
administer controlled substances only in the quantity and for the
length of time as are reasonably necessary.
11211. Purchases of Controlled Substances by Hospital Without
a Pharmacist for Emergencies; Conditions on Providing to
Patients
In order to provide a supply of controlled substances as may be
necessary to handle emergency cases, any hospital which does
not employ a resident pharmacist and which is under the
supervision of a licensed physician, may purchase controlled
substances on federal order forms for such institution, under the
name of such hospital, such supply to be made available to a
registered nurse for administration to patients in emergency
cases, upon direction of a licensed physician.
11212. Obtaining and Using Controlled Substance for Research,
Instruction, or Analysis; Conditions
Persons who, under applicable federal laws or regulations, are
lawfully entitled to use controlled substances for the purpose of
research, instruction, or analysis, may lawfully obtain and use for
such purposes those substances classified in paragraphs (45) and
(46) of subdivision (b) of Section 11054 of the Health and Safety
Code, upon registration with and approval by the California
Department of Justice for use of those substances in bona fide
research, instruction, or analysis.
That research, instruction, or analysis shall be carried on only
under the auspices of the individual identified by the registrant
as responsible for the research. Complete records of receipts,
stocks at hand, and use of these controlled substances shall be
kept.
The Department of Justice may withdraw approval of the use of
such substances at any time. The department may obtain and
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inspect at any time the records required to be maintained by this
section.
11213. Research Approval by Research Advisory Panel
Persons who, under applicable federal laws or regulations, are
lawfully entitled to use controlled substances for the purpose of
research, instruction, or analysis, may lawfully obtain and use for
such purposes such substances as are defined as controlled
substances in this division, upon approval for use of such
controlled substances in bona fide research, instruction, or
analysis by the Research Advisory Panel established pursuant to
Section 11480 and 11481.
Such research, instruction, or analysis shall be carried on only
under the auspices of the head of a research project which has
been approved by the Research Advisory Panel pursuant to
Section 11480 or Section 11481. Complete records of receipts,
stocks at hand, and use of these controlled substances shall be
kept.
Article 2. Treatment of Addicts for Addiction
11215. Administration of Narcotics By or Under Direction of
Physician, etc.; Who Physician May Direct to Administer
(a) Except as provided in subdivision (b), any narcotic controlled
substance employed in treating an addict for addiction shall be
administered by:
(1) A physician and surgeon.
(2) A registered nurse acting under the instruction of a physician
and surgeon.
(3) A physician assistant licensed pursuant to Chapter 7.7
(commencing with Section 3500) of Division 2 of the Business and
Professions Code acting under the patient-specific authority of
his or her physician and surgeon supervisor approved pursuant to
Section 3515 of the Business and Professions Code.
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(b) When acting under the direction of a physician and surgeon,
the following persons may administer a narcotic controlled
substance orally in the treatment of an addict for addiction to a
controlled substance:
(1) A psychiatric technician licensed pursuant to Chapter 10
(commencing with Section 4500) of Division 2 of the Business and
Professions Code.
(2) A vocational nurse licensed pursuant to Chapter 6.5
(commencing with Section 2840) of Division 2 of the Business and
Professions Code.
(3) A pharmacist licensed pursuant to Chapter 9 (commencing
with Section 4000) of Division 2 of the Business and Professions
Code.
(c) Except as permitted in this section, no person shall order,
permit, or direct any other person to administer a narcotic
controlled substance to a person being treated for addiction to a
controlled substance.
11217. Authorized Place of Treatment
Except as provided in Section 11223, no person shall treat an
addict for addiction to a narcotic drug except in one of the
following:
(a) An institution approved by the State Department of Health
Care Services, and where the patient is at all times kept under
restraint and control.
(b) A city or county jail.
(c) A state prison.
(d) A facility designated by a county and approved by the State
Department of Health Care Services pursuant to Division 5
(commencing with Section 5000) of the Welfare and Institutions
Code.
(e) A state hospital.
(f) A county hospital.
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(g) A facility licensed by the State Department of Health Care
Services pursuant to Division 10.5 (commencing with Section
11750).
(h) A facility as defined in subdivision (a) or (b) of Section 1250
and Section 1250.3.
A narcotic controlled substance in the continuing treatment of
addiction to a controlled substance shall be used only in those
programs licensed by the State Department of Health Care
Services pursuant to Article 1 (commencing with Section 11839)
of Chapter 10 of Part 2 of Division 10.5 on either an inpatient or
outpatient basis, or both.
This section does not apply during emergency treatment, or
where the patient’s addiction is complicated by the presence of
incurable disease, serious accident, or injury, or the infirmities of
old age.
Neither this section nor any other provision of this division shall
be construed to prohibit the maintenance of a place in which
persons seeking to recover from addiction to a controlled
substance reside and endeavor to aid one another and receive
aid from others in recovering from that addiction, nor does this
section or this division prohibit that aid, provided that no person
is treated for addiction in a place by means of administering,
furnishing, or prescribing of controlled substances. The preceding
sentence is declaratory of preexisting law.
Neither this section or any other provision of this division shall
be construed to prohibit short-term narcotic detoxification
treatment in a controlled setting approved by the director and
pursuant to rules and regulations of the director. Facilities and
treatment approved by the director under this paragraph shall
not be subject to approval or inspection by the Medical Board of
California, nor shall persons in those facilities be required to
register with, or report the termination of residence with, the
police department or sheriff’s office.
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11217.5. Administration in Office or Medical Facility of Non-
Narcotic Drugs
Notwithstanding the provisions of Section 11217, a licensed
physician and surgeon may treat an addict for addiction in any
office or medical facility which, in the professional judgment of
such physician and surgeon, is medically proper for the
rehabilitation and treatment of such addict. Such licensed
physician and surgeon may administer to an addict, under his
direct care, those medications and therapeutic agents which, in
the judgment of such physician and surgeon, are medically
necessary, provided that nothing in this section shall authorize
the administration of any narcotic drug.
11218. Limitation on Narcotics in First 15 Days of Treatment
A physician treating an addict for addiction may not prescribe
for or furnish to the addict more than any one of the following
amounts of controlled substances during each of the first 15 days
of that treatment:
(a) Eight grains of opium.
(b) Four grains of morphine.
(c) Six grains of Pantopon.
(d) One grain of Dilaudid.
(e) Four hundred milligrams of isonipecaine (Demerol).
11219. Limitation on Narcotics after First 15 Days of Treatment
After 15 days of treatment, the physician may not prescribe
for or furnish to the addict more than any one of the following
amounts of controlled substances during each day of the
treatment:
(a) Four grains of opium.
(b) Two grains of morphine.
(c) Three grains of Pantopon.
(d) One-half grain of Dilaudid.
(e) Two hundred milligrams of isonipecaine (Demerol).
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11220. Required Discontinuance of Controlled Substances,
Except Methadone or LAAM, After 30 Days
At the end of 30 days from the first treatment, the prescribing
or furnishing of controlled substances, except medications
approved by the federal Food and Drug Administration for the
purposes of narcotic replacement treatment or medication-
assisted treatment of substance use disorders, shall be
discontinued.
11222. Persons in Custody: Treatment for Withdrawal
Symptoms; Continued Participation in Narcotic Treatment
Programs
In any case in which a person is taken into custody by arrest or
other process of law and is lodged in a jail or other place of
confinement, and there is reasonable cause to believe that the
person is addicted to a controlled substance, it is the duty of the
person in charge of the place of confinement to provide the
person so confined with medical aid as necessary to ease any
symptoms of withdrawal from the use of controlled substances.
In any case in which a person, who is participating in a narcotic
treatment program, is incarcerated in a jail or other place of
confinement, he or she shall, in the discretion of the director of
the program, be entitled to continue in the program until
conviction.
Article 3. Veterinarians
11240. Prohibition on Prescribing, etc. Controlled Substance for
Human Being
No veterinarian shall prescribe, administer, or furnish a
controlled substance for himself or any other human being.
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11241. Prescription Contents
A prescription written by a veterinarian shall state the kind of
animal for which ordered and the name and address of the
owner or person having custody of the animal.
Article 4. Sale Without Prescription
11250. Authorized Retail Sale by Pharmacists to Physicians,
etc.; Required Order Form
(a) No prescription is required in case of the sale of controlled
substances at retail in pharmacies by pharmacists to any of the
following:
(1) Physicians.
(2) Dentists.
(3) Podiatrists.
(4) Veterinarians.
(5) Pharmacists acting within the scope of a project authorized
under Article 1 (commencing with Section 128125) of Chapter 3
of Part 3 of Division 107, or registered nurses acting within the
scope of a project authorized under Article 1 (commencing with
Section 128125) of Chapter 3 of Part 3 of Division 107, or
physician assistants acting within the scope of a project
authorized under Article 1 (commencing with Section 128125) of
Chapter 3 of Part 3 of Division 107.
(6) Optometrist.
(b) In any sale mentioned in this article, there shall be executed
any written order that may otherwise be required by federal law
relating to the production, importation, exportation,
manufacture, compounding, distributing, dispensing, or control
of controlled substances.
11251. Authorized Wholesale by Pharmacists
No prescription is required in case of sales at wholesale by
pharmacies, jobbers, wholesalers, and manufacturers to any of
the following:
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(a) Pharmacies as defined in the Business and Professions Code.
(b) Physicians.
(c) Dentists.
(d) Podiatrists.
(e) Veterinarians.
(f) Other jobbers, wholesalers or manufacturers.
(g) Pharmacists acting within the scope of a project authorized
under Article 1 (commencing with Section 128125) of Chapter 3
of Part 3 of Division 107, or registered nurses acting within the
scope of a project authorized under Article 1 (commencing with
Section 128125) of Chapter 3 of Part 3 of Division 107, or
physician assistants acting within the scope of a project
authorized under Article 1 (commencing with Section 128125) of
Chapter 3 of Part 3 of Division 107.
(h) Optometrists.
11252. Preservation of Federally Required Form
All wholesale jobbers, wholesalers, and manufacturers,
mentioned in this division shall keep, in a manner readily
accessible, the written orders or blank forms required to be
preserved pursuant to federal law relating to the production,
importation, exportation, manufacture, compounding,
distributing, dispensing, or control of controlled substances.
11253. Duration of Retention
The written orders or blank forms shall be preserved for at least
three years after the date of the last entry made.
11255. Actions Constituting Sale
The taking of any order, or making of any contract or
agreement, by any traveling representative or employee of any
person for future delivery in this state, of any controlled
substance constitutes a sale within the meaning of this division.
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11256. Required Report of Order by or Sale to Out-of-State
Wholesaler or Manufacturer
Within 24 hours after any purchaser in this state gives any order
for a controlled substance classified in Schedule II to, or makes
any contract or agreement for purchases from or sales by, an
out-of-state wholesaler or manufacturer of any controlled
substances for delivery in this state, the purchaser shall forward
to the Attorney General by registered mail a true and correct
copy of the order, contract, or agreement.
11364. Possession of Illegal Drug Paraphernalia
(a) It is unlawful to possess an opium pipe or any device,
contrivance, instrument, or paraphernalia used for unlawfully
injecting or smoking (1) a controlled substance specified in
subdivision (b), (c), or (e) or paragraph (1) of subdivision (f) of
Section 11054, specified in paragraph (14), (15), or (20) of
subdivision (d) of Section 11054, specified in subdivision (b) or (c)
of Section 11055, or specified in paragraph (2) of subdivision (d)
of Section 11055, or (2) a controlled substance that is a narcotic
drug classified in Schedule III, IV, or V.
(b) This section shall not apply to hypodermic needles or syringes
that have been containerized for safe disposal in a container that
meets state and federal standards for disposal of sharps waste.
(c) Until January 1, 2026, as a public health measure intended to
prevent the transmission of HIV, viral hepatitis, and other
bloodborne diseases among persons who use syringes and
hypodermic needles, and to prevent subsequent infection of
sexual partners, newborn children, or other persons, this section
shall not apply to the possession solely for personal use of
hypodermic needles or syringes.
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DIVISION 105. COMMUNICABLE DISEASE PREVENTION
AND CONTROL
CHAPTER 13. ACQUIRED IMMUNE DEFICIENCY SYNDROME
(AIDS) IMMUNIZATION
121281. Board Web Site: Testing for HIV and Viral Hepatitis;
Disposal of Sharps Waste; How to Access Drug Treatment
In order to assist pharmacists and pharmacy personnel in the
education of consumers who are at risk of bloodborne infections
regarding methods and opportunities for improving and
protecting their health, and thereby protect the public health,
the Office of AIDS shall develop and maintain all of the following
information, on its Internet Web site, and the California State
Board of Pharmacy shall also post, or maintain a link to, the
information on its Internet Web site:
(a) How consumers can access testing and treatment for HIV
and viral hepatitis.
(b) How consumers can safely dispose of syringes and
hypodermic needles or other sharps waste.
(c) How consumers can access drug treatment.
CHAPTER 18. CLEAN NEEDLE AND SYRINGE EXCHANGE
PROGRAM
121349. Legislative Findings and Declaration
(a) The Legislature finds and declares that scientific data from
needle exchange programs in the United States and in Europe
have shown that the exchange of used hypodermic needles and
syringes for clean hypodermic needles and syringes does not
increase drug use in the population, can serve as an important
bridge to treatment and recovery from drug abuse, and can
curtail the spread of human immunodeficiency virus (HIV)
infection among the intravenous drug user population.
709
(b) In order to reduce the spread of HIV infection and
bloodborne hepatitis among the intravenous drug user
population within California, the Legislature hereby authorizes a
clean needle and syringe exchange project pursuant to this
chapter in any city, county, or city and county upon the action of
a county board of supervisors and the local health officer or
health commission of that county, or upon the action of the city
council, the mayor, and the local health officer of a city with a
health department, or upon the action of the city council and the
mayor of a city without a health department.
(c) In order to reduce the spread of HIV infection, viral hepatitis,
and other potentially deadly bloodborne infections, the State
Department of Public Health may, notwithstanding any other
law, authorize entities that provide services set forth in
paragraph (1) of subdivision (d), and that have sufficient staff and
capacity to provide the services described in Section 121349.1, as
determined by the department, to apply for authorization under
this chapter to provide hypodermic needle and syringe exchange
services consistent with state standards in any location where
the department determines that the conditions exist for the
rapid spread of HIV, viral hepatitis, or any other potentially
deadly or disabling infections that are spread through the sharing
of used hypodermic needles and syringes. Authorization shall be
made after consultation with the local health officer and local law
enforcement leadership, and after a period of public comment,
as described in subdivision (e). In making the determination, the
department shall balance the concerns of law enforcement with
the public health benefits. The authorization shall not be for
more than two years. Before the end of the two-year period, the
department may reauthorize the program in consultation with
the local health officer and local law enforcement leadership.
(d) In order for an entity to be authorized to conduct a project
pursuant to this chapter, its application to the department shall
demonstrate that the entity complies with all of the following
minimum standards:
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(1) The entity provides, directly or through referral, all of the
following services:
(A) Drug abuse treatment services.
(B) HIV or hepatitis screening.
(C) Hepatitis A and hepatitis B vaccination.
(D) Screening for sexually transmitted infections.
(E) Housing services for the homeless, for victims of domestic
violence, or other similar housing services.
(F) Services related to provision of education and materials for
the reduction of sexual risk behaviors, including, but not limited
to, the distribution of condoms.
(2) The entity has the capacity to commence needle and syringe
exchange services within three months of authorization.
(3) The entity has adequate funding to do all of the following at
reasonably projected program participation levels:
(A) Provide needles and syringe exchange services for all of its
participants.
(B) Provide HIV and viral hepatitis prevention education services
for all of its participants.
(C) Provide for the safe recovery and disposal of used syringes
and sharps waste from all of its participants.
(4) The entity has the capacity, and an established plan, to
collect evaluative data in order to assess program impact,
including, but not limited to, all of the following:
(A) The total number of persons served.
(B) The total number of syringes and needles distributed,
recovered, and disposed of.
(C) The total numbers and types of referrals to drug treatment
and other services.
(e) If the application is provisionally deemed appropriate by the
department, the department shall, at least 45 days prior to
approval of the application, provide for a period of public
comment as follows:
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(1) Post on the department’s Internet Web site the name of the
applicant, the nature of the services, and the location where the
applying entity will provide the services.
(2) Send a written and an e-mail notice to the local health officer
of the affected jurisdiction.
(3) Send a written and an e-mail notice to the chief of police, the
sheriff, or both, as appropriate, of the jurisdictions in which the
program will operate.
(f) The department shall establish and maintain on its Internet
Web site the address and contact information of programs
providing hypodermic needle and syringe exchange services
pursuant to this chapter.
(g) The authorization provided under this section shall only be
for a clean needle and syringe exchange project as described in
Section 121349.1.
(h) If the department, in its discretion, determines that a state
authorized syringe exchange program continues to meet all
standards set forth in subdivision (d) and that a public health
need exists, it may administratively approve amendments to a
program’s operations including, but not limited to, modifications
to the time, location, and type of services provided, including the
designation as a fixed site or a mobile site. The amendment
approval shall not be subject to the noticing requirements of
subdivision (e).
(i) The department shall have 30 business days to review and
respond to the applicant’s request for amendment of the
authorization. If the department does not respond in writing
within 30 business days the request shall be deemed denied.
121349.1. Needle and Syringe Exchange Project; Requirements
The State Department of Public Health or a city, county, or a city
and county with or without a health department, that acts to
authorize a clean needle and syringe exchange project pursuant
to this chapter shall, in consultation with the State Department
of Public Health, authorize the exchange of clean hypodermic
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needles and syringes, as recommended by the United States
Secretary of Health and Human Services, subject to the
availability of funding, as part of a network of comprehensive
services, including treatment services, to combat the spread of
HIV and bloodborne hepatitis infection among injection drug
users. Staff and volunteers participating in an exchange project
authorized by the state, county, city, or city and county pursuant
to this chapter shall not be subject to criminal prosecution for
violation of any law related to the possession, furnishing, or
transfer of hypodermic needles or syringes or any materials
deemed by a local or state health department to be necessary to
prevent the spread of communicable diseases, or to prevent drug
overdose, injury, or disability during participation in an exchange
project. Program participants shall not be subject to criminal
prosecution for possession of needles or syringes or any
materials deemed by a local or state health department to be
necessary to prevent the spread of communicable diseases, or to
prevent drug overdose, injury, or disability acquired from an
authorized needle and syringe exchange project entity.
121349.2. Local, Health and Law Enforcement Comment
Annually, Public Input
Local government, local health officials, and law enforcement
shall be given the opportunity to comment on clean needle and
syringe exchange programs on a biennial basis. The public shall
be given the opportunity to provide input to local leaders to
ensure that any potential adverse impacts on the public welfare
of clean needle and syringe exchange programs are addressed
and mitigated.
121349.3. Annual Report of Health Officer of Participating
Jurisdiction
The health officer of the participating jurisdiction shall present
biennially at an open meeting of the board of supervisors or city
council a report detailing the status of clean needle and syringe
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exchange programs, including, but not limited to, relevant
statistics on bloodborne infections associated with needle
sharing activity and the use of public funds for these programs.
Law enforcement, administrators of alcohol and drug treatment
programs, other stakeholders, and the public shall be afforded
ample opportunity to comment at this biennial meeting. The
notice to the public shall be sufficient to ensure adequate
participation in the meeting by the public. This meeting shall be
noticed in accordance with all state and local open meeting laws
and ordinances, and as local officials deem appropriate. For
hypodermic needle and syringe exchange services authorized by
the State Department of Public Health, a biennial report shall be
provided by the department to the local health officer based on
the reports to the department from service providers within the
jurisdiction of that local health officer.
DIVISION 106. PERSONAL HEALTH CARE
PART 4.5. PAIN PATIENT’S BILL OF RIGHTS
124960. Treatment of Severe Chronic Intractable Pain
The Legislature finds and declares all of the following:
(a) The state has a right and duty to control the illegal use of
opiate drugs.
(b) Inadequate treatment of acute and chronic pain originating
from cancer or noncancerous conditions is a significant health
problem.
(c) For some patients, pain management is the single most
important treatment a physician can provide.
(d) A patient suffering from severe chronic intractable pain
should have access to proper treatment of his or her pain.
(e) Due to the complexity of their problems, many patients
suffering from severe chronic intractable pain may require
referral to a physician with expertise in the treatment of severe
chronic intractable pain. In some cases, severe chronic
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intractable pain is best treated by a team of clinicians in order to
address the associated physical, psychological, social, and
vocational issues.
(f) In the hands of knowledgeable, ethical, and experienced pain
management practitioners, opiates administered for severe
acute pain and severe chronic intractable pain can be safe.
(g) Opiates can be an accepted treatment for patients in severe
chronic intractable pain who have not obtained relief from any
other means of treatment.
(h) A patient suffering from severe chronic intractable pain has
the option to request or reject the use of any or all modalities to
relieve his or her pain.
(i) A physician treating a patient who suffers from severe
chronic intractable pain may prescribe a dosage deemed
medically necessary to relieve pain as long as the prescribing is in
conformance with Section 2241.5 of the Business and Professions
Code.
(j) A patient who suffers from severe chronic intractable pain
has the option to choose opiate medication for the treatment of
the severe chronic intractable pain as long as the prescribing is in
conformance with Section 2241.5 of the Business and Professions
Code.
(k) The patient’s physician may refuse to prescribe opiate
medication for a patient who requests the treatment for severe
chronic intractable pain. However, that physician shall inform the
patient that there are physicians who treat severe chronic
intractable pain with methods that include the use of opiates.
124961. Pain Patient’s Bill of Rights
Nothing in this section shall be construed to alter any of the
provisions set forth in Section 2241.5 of the Business and
Professions Code. This section shall be known as the Pain
Patient’s Bill of Rights.
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(a) A patient who suffers from severe chronic intractable pain
has the option to request or reject the use of any or all modalities
in order to relieve his or her pain.
(b) A patient who suffers from severe chronic intractable pain
has the option to choose opiate medications to relieve that pain
without first having to submit to an invasive medical procedure,
which is defined as surgery, destruction of a nerve or other body
tissue by manipulation, or the implantation of a drug delivery
system or device, as long as the prescribing physician acts in
conformance with the California Intractable Pain Treatment Act,
Section 2241.5 of the Business and Professions Code.
(c) The patient’s physician may refuse to prescribe opiate
medication for the patient who requests a treatment for severe
chronic intractable pain. However, that physician shall inform the
patient that there are physicians who treat pain and whose
methods include the use of opiates.
(d) A physician who uses opiate therapy to relieve severe
chronic intractable pain may prescribe a dosage deemed
medically necessary to relieve the patient’s pain, as long as that
prescribing is in conformance with Section 2241.5 of the Business
and Professions Code.
(e) A patient may voluntarily request that his or her physician
provide an identifying notice of the prescription for purposes of
emergency treatment or law enforcement identification.
(f) Nothing in this section shall do either of the following:
(1) Limit any reporting or disciplinary provisions applicable to
licensed physicians and surgeons who violate prescribing
practices or other provisions set forth in the Medical Practice Act,
Chapter 5 (commencing with Section 2000) of Division 2 of the
Business and Professions Code, or the regulations adopted
thereunder.
(2) Limit the applicability of any federal statute or federal
regulation or any of the other statutes or regulations of this state
that regulate dangerous drugs or controlled substances.
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DIVISION 106. PERSONAL HEALTH CARE
PART 5. HEREDITARY DISEASES/CONGENITAL DEFECTS
CHAPTER 2. GENETIC DISEASE SERVICES
Article 5. Standards of Service for Providers of
Blood Clotting Products for Home Use Act
125286.10. Article Title
This article shall be known, and may be cited, as the Standards
of Service for Providers of Blood Clotting Products for Home Use
Act.
125286.15. Legislative Declarations
The Legislature hereby finds and declares all of the following:
(a) Hemophilia is a rare, hereditary, bleeding disorder affecting
at least 4,000 persons in California and is a chronic, lifelong, and
incurable, but treatable, disease.
(b) Von Willebrand disease is a human bleeding disorder caused
by a hereditary deficiency or abnormality of the von Willebrand
factor in human blood, which is a protein that helps clot blood.
Von Willebrand disease is a chronic, lifelong, incurable, but
treatable, disease affecting at least 360,000 Californians.
(c) Until the 1970s, people with severe hemophilia suffered
from uncontrollable internal bleeding, crippling orthopedic
deformities, and a shortened lifespan. More recently, the
production of highly purified blood clotting factors has provided
people with hemophilia and other bleeding disorders the
opportunity to lead normal lives, free of pain and crippling
arthritis.
(d) The preferred method of treatment of hemophilia today is
intravenous injection, or infusion, of prescription blood clotting
products several times per week, along with case management
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and specialized medical care at a federally designated regional
hemophilia treatment center.
(e) Pharmacies and other entities specializing in the delivery of
blood clotting products and related equipment, supplies, and
services for home use form a growing enterprise in California.
(f) Timely access to federally designated regional hemophilia
centers and appropriate products and services in the home,
including infusion of blood clotting products and related
equipment, and supplies and services for persons with
hemophilia and other bleeding disorders, reduces mortality and
bleeding-related hospitalizations according to the federal Centers
for Disease Control and Prevention and the Medical and Scientific
Advisory Council of the National Hemophilia Foundation.
(g) Eligible persons with hemophilia or other bleeding disorders
may receive treatment through the Genetically Handicapped
Persons Program, the California Children’s Services Program, and
the Medi-Cal program.
(h) For the benefit of persons with hemophilia or other bleeding
disorders, the purposes of this article are to do the following:
(1) Establish standards of service for entities that deliver blood
clotting products and related equipment, supplies, and services
for home use.
(2) Promote access to a full range of essential, cost-effective,
lifesaving, blood clotting products and related equipment,
supplies, and high-quality services for home use for persons with
hemophilia and other bleeding disorders.
125286.20. Definitions
Unless the context otherwise requires, the following definitions
shall apply for purposes of this article:
(a) “Assay” means the amount of a particular constituent of a
mixture or of the biological or pharmacological potency of a drug.
(b) “Ancillary infusion equipment and supplies” means the
equipment and supplies required to infuse a blood clotting
product into a human vein, including, but not limited to, syringes,
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needles, sterile gauze, field pads, gloves, alcohol swabs, numbing
creams, tourniquets, medical tape, sharps or equivalent
biohazard waste containers, and cold compression packs.
(c) “Bleeding disorder” means a medical condition characterized
by a deficiency or absence of one or more essential blood clotting
proteins in the human blood, often called “factors,” including all
forms of hemophilia and other bleeding disorders that, without
treatment, result in uncontrollable bleeding or abnormal blood
clotting.
(d) “Blood clotting product” means an intravenously
administered medicine manufactured from human plasma or
recombinant biotechnology techniques, approved for distribution
by the federal Food and Drug Administration, that is used for the
treatment and prevention of symptoms associated with bleeding
disorders. Blood clotting products include, but are not limited to,
factor VII, factor VIIa, factor VIII, and factor IX products, von
Willebrand factor products, bypass products for patients with
inhibitors, and activated prothrombin complex concentrates.
(e) “Emergency” means care as defined in Section 1317.1.
(f) “Hemophilia” means a human bleeding disorder caused by a
hereditary deficiency of the factor I, II, V, VIII, IX, XI, XII, or XIII
blood clotting protein in human blood.
(g) “Hemophilia treatment center” means a facility for the
treatment of bleeding disorders, including, but not limited to,
hemophilia, that receives funding specifically for the treatment of
patients with bleeding disorders from federal government
sources, including, but not limited to, the federal Centers for
Disease Control and Prevention and the federal Health Resources
and Services Administration (HRSA) of the United States
Department of Health and Human Services.
(h) “Home use” means infusion or other use of a blood clotting
product in a place other than a state-recognized hemophilia
treatment center or other clinical setting. Places where home use
occurs include, without limitation, a home or other nonclinical
setting.
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