Senate Bill S8593

                                 
BILL NUMBER: S8593

SPONSOR: KRUEGER
 
TITLE OF BILL:

An act to amend the education law, in relation to permitting licensed
pharmacists to prescribe and order certain medications for the purposes
of inducing abortion or expelling a miscarriage

 
PURPOSE:

To increase access to abortion medication by authorizing licensed phar-
macists to prescribe and dispense such medication.

 
SUMMARY OF PROVISIONS:

Section one of the bill amends section 6801 of the education law to
authorizing a licensed pharmacist to prescribe, order, and dispense
medications approved by the FDA for the purposes of inducing abortion or
expelling a miscarriage. Prior to dispensing medication, the pharmacist
must: provide a risk assessment questionnaire, developed by the commis-
sioner of health in consultation with the commissioner, to the patient
              

to be reviewed by the pharmacist to identify any risk factors and
provide a fact sheet, developed by the commissioner of health in consul-
tation with the commissioner, that includes clinical considerations,
appropriate methods for using abortion medication, information on follow
up care, and health care referral information.

This section also provides that no pharmacist shall prescribe or
dispense abortion medication without receiving training satisfactory to
the commissioner of education. Additionally, nothing shall prevent a
pharmacist from refusing to prescribe or dispense abortion medication
if, in their professional judgement, potential adverse effects could
endanger the health of the patient.

Section two provides the effective date.

 
JUSTIFICATION:

For decades, mifepristone - a crucial component of the 2-drug medication
abortion regimen - has been documented and demonstrated as safe and
effective. The medication is highly effective and serious complications
from mifepristone are exceedingly rare, with rates of major adverse
events well under 1 percent.* In fact, data analysis has shown that
mifepristone is even safer than some prescription drugs, like penicillin
and Viagra. **

Despite the demonstrated safety of mifepristone, the federal government
has required a Risk Evaluation and Mitigation Strategy on the medica-
tion. A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety
program that the federal government can require for certain medications.
In practice, REMS place several restrictions on the medication's
distribution and use, making it more difficult to access. The American
College of Obstetricians and Gynecologists (ACOG) has advocated, for the
removal of the REMS restrictions on mifepristone because "they do not
make the care safer; are not based on medical evidence or need; create
barriers to clinician and patient access to medication abortion and
medical management of early pregnancy loss; and disproportionately
burden communities already facing structural barriers to care, including
people of color and those living long distances from a health care
professional." **

Prior to 2023, the REMS restrictions included an in-person dispensing
requirement, meaning mifepristone could only be dispensed in a clinic,
medical office, or hospital under the direct supervision of a clinician.
However, in 2023, the federal government removed the in-person dispens-
ing requirement but maintains a patient must sign an agreement form from
a provider authorized to prescribe the medication. So, while mifepri-
stone can now be dispensed in a pharmacy and not only in a doctor's
office or hospital, a patient must first meet with a provider authorized
to prescribe before the medication is dispensed.

This presents many challenges for women in New York State in need of the
medication as there are often difficulties encountered in obtaining
medical appointments at offices with limited hours, long waits, or
inconvenient locations. In rural areas of the state, the challenges are
even greater as there is an acute shortage of Ob/Gyn physicians. The
Office of the State Comptroller reported that of the 16 rural counties,
there is approximately 1 Ob/Gyn for every 23,000 people and four of the
16 rural counties have no Ob/Gyn providers at all. ****

In addition to the current REMS restrictions on mifepristone, Health and
Human Services Secretary Robert F. Kennedy, Jr., recently announced that
he has directed the FDA to undertake a review of regulations on mifepri-
stone, inferring its safety and efficacy is up for debate. This is yet
another example of the federal government politicizing public health
and, like we've seen with COVID-19 vaccines, restricting access to crit-
ically important and evidence-based public health tools.

New York State has found a way to circumvent federal obstacles to
accessing COVID-19 vaccines by authorizing pharmacists to prescribe
immunizations so New Yorkers can easily and conveniently receive a
vaccine at their local pharmacy. Similarly, this bill would authorize
licensed pharmacists to prescribe and dispense abortion medication so
that all New Yorkers, regardless of their proximity to a reproductive
health provider, can continue to access the care they need.

Federal barriers to accessing abortion medication put New Yorkers'
health at risk, this legislation will ensure access to safe and effec-
tive reproductive health care for all.

 
LEGISLATIVE HISTORY:

New bill

 
FISCAL IMPLICATIONS:

None

 
EFFECTIVE DATE:
Immediate
* https://www.accessdata.fda.gov/drugsatfda_docs/label/
2016/020687s020lb.pdf
**** https://www.cnn.com/2023/03/15/health/abortion-piLl-safety-dg/
index.html
***https://www.acog.org/clinicaUclinical-guidance/practice-
advisory/articles/2023/01/updated-mifepristone-rems-requirements
**** https://www.osc.ny.gov/files/reports/pdf/rural-health- shortag-
es.pdf