NEW YORK STATE ASSEMBLY MEMORANDUM IN SUPPORT OF LEGISLATION submitted in accordance with Assembly Rule III, Sec 1(f)
 
BILL NUMBER: A3040B
SPONSOR: McDonald
 
TITLE OF BILL:
An act to amend the education law, in relation to the definition of the
practice of pharmacy
 
PURPOSE OR GENERAL IDEA OF BILL:
This bill allows pharmacists to administer injectable medications for
substance use disorders and mental health.
 
SUMMARY OF SPECIFIC PROVISIONS:
Section 1 amends Education Law Section 6802, subdivision 22 as added by
chapter 555 of the laws of 2021 to include pharmacist administered
injections for mental health and substance use disorders within the
definition of administer and sets out the parameters for the
prescription and order, training, record keeping, and reporting.
Section 2 amends Education Law Section 6801 to add a new subdivision 8
to include pharmacist administered injections in the deltoid for mental
health and substance use disorders within the definition of administer
and sets out the parameters for the prescription and order, training,
record keeping, and reporting.
Section 3 establishes the effective date.
JUSTIFICATION:
New York is one of 11 states that do not allow pharmacist medication
administrative authority for non-vaccine items and one of 14 states that
do not allow pharmacists the administrative authority to administer
Long-Acting Injectable Antipsychotics.
There is a public health need in the US for increased access to behav-
ioral health services-including Long Acting Injectables (LAIS) that are
either used for mental health or substance use disorders. The challenge
with the oral forms of these medications is non-adherence, which is very
prevalent. For example, half of patients diagnosed with schizophrenia do
not take their medications as prescribed and re-admission rates are five
times higher in patients who are non-adherent than those who are adher-
ent. This high rate of non-adherence can be linked to many reasons
including the side effects of the medications, diversion and other
factors that can contribute to clinical relapses and hospitalizations
which can cause significant distress for the patient and high costs to
the health care system. More importantly, treatment goals are not being
met which is of benefit to the patient and society as a whole.
Due to the high accessibility of community pharmacies that are much
closer to patient's homes and have more extensive hours of operations
than a clinic setting, pharmacists are well suited to administer LAIs in
the community setting. Additionally, pharmacies are able to provide
on-demand or appointment-based delivery as has been implemented for
vaccine administration and they are well equipped to maintain a large
medication inventory, something medical offices are not well-suited for.
Moreover, the ability to allow pharmacists to administer LAI's in the
community setting will also help reduce the stigma of patients who need
to go to a specific type of clinic for their disease which at times is
not only a challenge with transportation but also with how they feel
they will be perceived. In addition, the COVID-19 pandemic may make a
patient less likely to travel to a traditional medical setting. Final-
ly, in the community pharmacy setting, pharmacies are able to include
policies and procedures for communicating care delivery back to the
patient's health care provider and other coordination services which is
critical information that a provider cannot always access easily.
This bill will improve patient access and adherence while reducing stig-
ma at a time when a growing number of individuals in our communities are
struggling with mental health concerns and/or a substance abuse disor-
der.
 
PRIOR LEGISLATIVE HISTORY:
2017-2018 A.8661
 
FISCAL IMPLICATIONS:
None.
 
EFFECTIVE DATE:
This act shall take effect one year after it shall have become law,
subject to additional provisions.
STATE OF NEW YORK
________________________________________________________________________
3040--B
2021-2022 Regular Sessions
IN ASSEMBLY
January 22, 2021
___________
Introduced by M. of A. McDONALD, BLANKENBUSH, TAGUE, WALCZYK, BRABENEC,
GOTTFRIED, JACKSON, STIRPE, GUNTHER, GRIFFIN, STECK, LUPARDO, BUTTENS-
CHON, WOERNER -- Multi-Sponsored by -- M. of A. SAYEGH -- read once
and referred to the Committee on Higher Education -- recommitted to
the Committee on Higher Education in accordance with Assembly Rule 3,
sec. 2 -- committee discharged, bill amended, ordered reprinted as
amended and recommitted to said committee -- again reported from said
committee with amendments, ordered reprinted as amended and recommit-
ted to said committee
AN ACT to amend the education law, in relation to the definition of the
practice of pharmacy
The People of the State of New York, represented in Senate and Assem-bly, do enact as follows:
1 Section 1. Subdivision 22 of section 6802 of the education law, as
2 amended by chapter 555 of the laws of 2021, is amended to read as
3 follows:
4 22. "Administer", for the purpose of section sixty-eight hundred one
5 of this article, means:
6 a. (1) the direct application of an immunizing agent to adults, wheth-
7 er by injection, ingestion, inhalation or any other means, pursuant to a
8 patient specific order or non-patient specific regimen prescribed or
9 ordered by a physician or certified nurse practitioner, for: immuniza-
10 tions to prevent influenza, pneumococcal, acute herpes zoster, hepatitis
11 A, hepatitis B, human papillomavirus, measles, mumps, rubella, varicel-
12 la, COVID-19, meningococcal, tetanus, diphtheria or pertussis disease
13 and medications required for emergency treatment of anaphylaxis; and
14 other immunizations recommended by the advisory committee on immuniza-
15 tion practices of the centers for disease control and prevention for
16 patients eighteen years of age or older if the commissioner of health in
17 consultation with the commissioner determines that an immunization:
18 (i)(A) may be safely administered by a licensed pharmacist within their
EXPLANATION--Matter in italics (underscored) is new; matter in brackets
[] is old law to be omitted.
LBD03519-08-2
A. 3040--B 2
1 lawful scope of practice; and (B) is needed to prevent the transmission
2 of a reportable communicable disease that is prevalent in New York
3 state; or (ii) is a recommended immunization for such patients who: (A)
4 meet age requirements, (B) lack documentation of such immunization, (C)
5 lack evidence of past infection, or (D) have an additional risk factor
6 or another indication as recommended by the advisory committee on immun-
7 ization practices of the centers for disease control and prevention. If
8 the commissioner of health determines that there is an outbreak of
9 disease, or that there is the imminent threat of an outbreak of disease,
10 then the commissioner of health may issue a non-patient specific regimen
11 applicable statewide.
12 [b.] (2) the direct application of an immunizing agent to children
13 between the ages of two and eighteen years of age, whether by injection,
14 ingestion, inhalation or any other means, pursuant to a patient specific
15 order or non-patient specific regimen prescribed or ordered by a physi-
16 cian or certified nurse practitioner, for immunization to prevent influ-
17 enza and medications required for emergency treatment of anaphylaxis
18 resulting from such immunization. If the commissioner of health deter-
19 mines that there is an outbreak of influenza, or that there is the immi-
20 nent threat of an outbreak of influenza, then the commissioner of health
21 may issue a non-patient specific regimen applicable statewide.
22 b. The injection of medications into the deltoid muscle for the treat-
23 ment of mental health and substance use disorder, as prescribed or
24 ordered by a licensed prescriber, acting within the scope of their prac-
25 tice in this state and in accordance with regulations promulgated by the
26 commissioner and the department of health in consultation with any other
27 state agencies as necessary, but not be limited to, providing that:
28 (1) Such administration is conducted pursuant to a valid prescription
29 or order that authorizes a pharmacist to administer medications for the
30 treatment of mental health and substance use disorder and the pharmacist
31 notifies the licensed prescriber that the administration is complete.
32 Administration in a pharmacy may not commence until after the patient
33 has received the initial injection and is considered eligible for main-
34 tenance treatment by the licensed prescriber.
35 (2) Such prescription may be subject to reassessment at appropriate
36 intervals, as determined by the licensed prescriber.
37 (3) Such activity is conducted in accordance with regulations, promul-
38 gated or adopted by the commissioner and the department of health, in
39 consultation with any other state agencies, as necessary, which shall
40 include requirements for the following:
41 (i) Training accredited by the accreditation council for pharmacy
42 education, that may include educational experiences obtained through
43 pharmacy school curricula, or a similar health authority or professional
44 body appropriate for the medications being administered and their
45 respective patient populations. Such training must be satisfactory to
46 the commissioner and the department of health, in consultation with the
47 board of pharmacy and any other state agencies, as necessary, which
48 shall include, but not be limited to learning modules on techniques for
49 administration by injections, indications, precautions, and contraindi-
50 cations in the use of agent or agents; record keeping and information;
51 and handling emergencies, including anaphylaxis, needle-sticks and
52 cardiopulmonary resuscitation.
53 (ii) Maintaining continued competency regarding the populations served
54 and medications administered.
55 (iii) Pre-administration patient consent and education regarding
56 common side effects, drug interactions, injection site reactions and
A. 3040--B 3
1 other information routinely provided to patients upon dispensing. If a
2 patient is unable to provide consent, the pharmacist must obtain consent
3 from a person legally responsible when the recipient is incapable of
4 consenting.
5 (iv) When administering an injection in a pharmacy, the pharmacist
6 shall provide an area for the injection that provides for the patient's
7 privacy.
8 (v) Record keeping and reporting of such administration by electronic
9 transmission or facsimile to the patient's licensed prescriber, and, to
10 the extent practicable, make himself or herself available to discuss the
11 outcome of such injection, including any adverse reactions, with the
12 licensed prescriber acting within their scope of practice.
13 § 2. Section 6801 of the education law is amended by adding a new
14 subdivision 8 to read as follows:
15 8. A licensed pharmacist within their lawful scope of practice may
16 administer injectable medications into the deltoid muscle, pursuant to
17 section six thousand eight hundred two of this article, for the treat-
18 ment of mental health and substance use disorder, as prescribed or
19 ordered by a licensed prescriber, acting within their scope of practice
20 in this state and in accordance with regulations, including but not
21 limited to regulations promulgated by the commissioner in consultation
22 with any other state agencies, as necessary.
23 § 3. This act shall take effect one year after it shall have become a
24 law. Effective immediately, the addition, amendment and/or repeal of any
25 rule or regulation necessary for the implementation of this act on its
26 effective date are authorized to be made and completed by the commis-
27 sioner of education on or before such date.