Senate Bill S3808B

                                BILL NUMBER:S3808

TITLE OF BILL:
An act
to amend the education law, in relation to the practice of pharmacy

PURPOSE:
To allow a pharmacist certified by the Education Department
to administer immunizations formulated in adult dosage, to allow
pharmacy interns and residents registered with the department who
have completed immunization certification requirements to administer
immunizations under the direct supervision of a licensed pharmacist
certified to immunize, to allow the certification fee to be collected
by the department with the initial application and to repeal the
sunset.

SUMMARY OF PROVISIONS:
Section one amends Section 6801 of the
education law by adding a new provision in paragraph two that
streamlines the reporting of immunizations administered to adults in
clinics and facilities licensed under article twenty-eight of the
public health law and immunization outreach programs authorized by
state or county public health departments.

Section one adds a new provision to allow a pharmacy intern or
resident registered with the department who has successfully
              

completed every requirement for the Certificate of Administration to
administer an immunization under the direct supervision of a licensed
pharmacist who has a valid Certificate of Administration issued by
the department.

Section two of the bill amends Subdivision 22 of Section 6802 of the
education law to remove the county restriction in current statute
that applies to the physician or nurse practitioner issuing a
patient-specific or non-patient specific order to a licensed
pharmacist certified by the department to immunize.

Section two of the bill allows the licensed pharmacist certified by
the department to immunize to administer any vaccine formulated in
adult dosage, broadening provisions in current law that limit
pharmacists to flu and pneumococcal vaccines.

Section three of the bill establishes that the fee of $100 applies to
the original application.

Section four of the bill removes the sunset provision.

JUSTIFICATION:
In the past two years New York's adult immunization
rates have risen dramatically. As in other states, broadening access
to vaccines by allowing pharmacists to immunize significantly
improved progress toward established public health goals. Since
implementation in the fall of 2008, more than 5,000 NYS licensed
pharmacists completed certification requirements. By some estimates,
pharmacists administered more than one million immunizations in New
York in the past twelve months meeting established clinical


standards. Clearly, this initiative has been successful by any
measure and the sunset should therefore be removed.

Despite significant gains, a recent report entitled "Adult
Immunization: Shots to Save Lives" released in February, 2010, by
the Trust for American's Health, the Infectious Diseases Society of
America and the Robert Wood Johnson Foundation found that as of 2008
nationally more than thirty percent of adults over 65 had not been
immunized against pneumonia in 36 states. The report cites New York's
rate of pneumococcal immunization for adults to be 36.7%, slightly
above the national average but still low in terms of prevention and
the cost to treat vaccine preventable illness and hospitalization.

Effective immunization programs against seasonal flu represent a
public health challenge that recurs every year, and from this
perspective it is essential that New York's law not be allowed to
sunset. Furthermore, a recent analysis published in Biosecurity and
Bioterrorism: "Biodefense Strategy, Practice and Science" recommends
that "Building capacity around seasonal influenza vaccine programs
would serve a dual purpose: providing protection against seasonal
influenza and preparing the country for a future severe influenza
pandemic."

Another provision of the current law that emerged as a significant
barrier particularly in jurisdictions outside of New York City was
the restriction placed on the authorizing physicians and nurse
practitioners, that their non-patient specific orders could apply only
to the county in which they practice. For months in some counties,
certified pharmacists remained inactive, lacking the required
authorization. In many cases, access to adult immunizations was
unnecessarily restricted by this provision and for this reason it
should be removed.

The most significant change in law under this legislation is
broadening the vaccines that pharmacists would be allowed to
administer to include any vaccine formulated in an adult dose, as is
allowed in most states. In this context, it is important to point out
provisions in the bill under which pharmacists are authorized to
administer vaccines. Before a certified pharmacist can immunize an
individual, the pharmacist must have a patient-specific order or
non-patient-specific order issued by a physician or nurse
practitioner that specifies the vaccine to be administered and under
what specific protocol. These are the actual limitations under which
pharmacists administer any vaccine. It is anticipated that the most
common authorizations will be for flu and pneumococcal immunizations,
but the statute is broad enough to allow a physician who is a county
health official or the the NYS Commissioner of Health to respond to
an outbreak of pertussis in adults or any other vaccine-preventable
disease that is prevalent in the state or a specific geographic
region. This provision also allows physicians to give their patients
greater access to vaccines that are available at a local pharmacy and
not available in the physician's office.

Another rationale for broadening the list of vaccines is that
pharmacist-administration of vaccines is common across the country.
Medicare Part D allows pharmacies to submit claims for vaccines and
vaccine administration, moving adult immunization into the 'pharmacy


benefit'. This provision is a national policy response to the need to
improve the rate of adult immunization consistent with the
recommendations of the Centers for Disease Control. Prevention is a
cost-containment tool as well as a public health goal.

In addition, more and more physician offices have limited their supply
of vaccines on hand due to cost, special handling requirements or
other reasons. Consider, for example, the herpes zoster vaccine that
prevents shingles" (Shingles is a painful disease characterized by
inflammation of the nerve endings.) The target group for this
vaccination is adults 60 years of age or older. The vaccine must be
protected from light and stored in a freezer. It may be stored or
transported at 36 - 46 degrees Fahrenheit, but if it is, it must be
used within 72 hours. Stored improperly, the vaccine must destroyed.
Its cost is $200 per dose.

Whooping cough is an emerging public health concern in adults, having
caused several deaths in New York. Adult immunization rates have
traditionally been low and pharmacists could under these new
provisions be authorized to administer the one-time booster (TDap) in
regions that are identified by public health officials. TDap is
recommended by the CDC for adults. It is anticipated that regulations
developed by the Education Department would refer to the CDC and
other national public health sources for the list of specific
vaccines formulated in adult doses that pharmacists would be
authorized under this bill to administer.

It is important to note that under Governor Paterson's 2010 Executive
Order (responding to concern over the HINI pandemic), pharmacists
competently immunized New Yorkers of all ages, within guidelines
established by the Health Department That experience provides the
basis for a new provision, namely that when a pharmacist administers
a vaccine in a clinic or alternative distribution program under the
aegis of public health officials, the
immunizing pharmacist should not be required to report to the
patient's primary care provider unless the reporting requirement
applies equally to other licensed healthcare professionals at the site.

Entering the pharmacy profession today requires candidates to
complete a six-year program leading to the Doctor of Pharmacy degree.
Sixth-year pharmacy students are residents and interns in practice
sites that include hospitals, clinics and community pharmacies, Those
who have successfully completed every requirement for certification
as immunizers represent an additional resource for broadening the
public's access to adult vaccines, and for this reason pharmacy
interns and residents should be allowed to administer under the
supervision of a licensed pharmacist who holds a valid immunization
certificate and who has been authorized to administer specified
vaccines by a physician or nurse practitioner. Were an emergency
situation to arise, this provision in the bill increases the state's
preparedness assets.

It is appropriate that the $100 fee that pharmacists remit to the
education department with an application for the certificate of
administration becomes a one-time fee because department resources
are used to review the initial application and establish that the
applicant met all the requirements. Once a pharmacist has the


administration certificate, renewal should be automatic at the same
time the license is renewed, every three years, In addition, this
change in statute is consistent with policies of the department that
apply to other licensed health professions. In terms of public
protection, it is important to note that the Office of Professional
Discipline's authority includes revoking a pharmacist's certificate
of administration should such an action become necessary,

LEGISLATIVE HISTORY:
None.

FISCAL IMPLICATIONS:
None.

EFFECTIVE DATE:
This act shall take effect on the ninetieth day after
it shall have become law, with provisions.

                                BILL NUMBER:S3808A

TITLE OF BILL:
An act
to amend the education law, in relation to the practice of pharmacy
and to amend chapter 563 of the laws of 2008 amending the
education law and the public health law relating to immunizing
agents to be administered to adults by pharmacists,
in relation to making such provisions permanent

PURPOSE:
To allow a pharmacist certified by the Education Department
to administer vaccines to adults recommended by the Centers for
Disease Control and Prevention on the adult immunization schedule, to
allow pharmacy interns and residents registered with the department
who have completed immunization certification requirements to
administer immunizations under the direct supervision of a licensed
pharmacist certified to immunize, to allow the certification fee to
be collected by the department with the initial application and to
repeal the sunset.

SUMMARY OF PROVISIONS:
Section one amends section 6801 of the
education law to add a new.
provision to allow a pharmacy intern or resident registered with the
department who has successfully completed every requirement for the
              

Certificate of Administration to administer an immunization under
the direct supervision of a licensed pharmacist who has a valid
Certificate of Administration issued by the department.

Section two of the bill amends Subdivision 22 of Section 6802 of the
education law to remove the county restriction in current statute
that applies to the physician or nurse practitioner issuing a
patient-specific or non-patient specific order to a licensed
pharmacist certified by the department to immunize.

Section two of the bill allows the licensed pharmacist certified by
the department to immunize to administer any vaccine to adults that
is listed in the recommended adult immunization schedule by the
Centers for Disease Control and Prevention, broadening provisions in
current law that limit pharmacists to flu and pneumococcal vaccines.

Section three of the bill establishes that the fee of $1 00 applies to
the original application.

Section four of the bill removes the sunset provision.

Section five of the bill provides the effective date.

JUSTIFICATION:
In the past two years New York's adult immunization
rates have risen dramatically. As in other states, broadening access
to vaccines by allowing pharmacists to immunize significantly
improved progress toward established public health goals. Since
implementation in the fall of2008, more than 5,000 NYS licensed
pharmacists completed certification requirements. By some estimates,


pharmacists administered more than one million immunizations in New
York in the past twelve months meeting established clinical standards.
Clearly, this initiative has been successful by any measure and the
sunset should therefore be removed.

Despite significant gains, a recent report entitled "Adult
Immunization: Shots to Save Lives" released in February, 2010, by the
Trust for American's Health, the Infectious Diseases Society of
America and the Robert Wood Johnson Foundation found that as of2008
nationally more than thirty percent of adults over 65 had not been
immunized against pneumonia in 36 states. The report cites New York's
rate of pneumococcal immunization for adults to be 36.7%, slightly
above the national average but still low in terms of prevention and
the cost to treat vaccine preventable illness and hospitalization.

Effective immunization programs against seasonal flu represent a
public health challenge that recurs every year, and from this
perspective it is essential that New York's law not be allowed to
sunset. Furthermore, a recent analysis published in Biosecurity and
Bioterrorism: "Biodefense Strategy, Practice and Science" recommends
that "Building capacity around seasonal influenza vaccine programs
would serve a dual purpose: providing protection against seasonal
influenza and preparing the country for a future severe influenza
pandemic."

Another provision of the current law that emerged as a significant
barrier particularly in jurisdictions outside of New York City was
the restriction placed on the authorizing physicians and nurse
practitioners, that their non-patient specific orders could apply
only to the county in which they practice. For months in some
counties, certified pharmacists remained inactive, lacking the
required authorization. In many cases, access to adult immunizations
was unnecessarily restricted by this provision and for this reason it
should be removed.

The most significant change in law under this legislation is
broadening the vaccines that pharmacists would be allowed to
administer to adults, as is allowed in most states. In this context,
it is important to point out provisions in the bill under which
pharmacists are authorized to administer vaccines. Before. a
certified pharmacist can immunize an individual, the pharmacist must
have a patient-specific order or non patient specific order issued by
a physician or nurse practitioner that specifies the vaccine to be
administered and under what specific protocol. These are the actual
limitations under which pharmacists administer any vaccine. It is
anticipated that the most common authorizations will be for flu and
pneumococcal immunizations, but the statute is broad enough to allow
a physician, nurse practitioner or the NYS Commissioner of Health to
respond to an outbreak of pertussis in adults or any other
vaccine-preventable disease that is prevalent in the state or a
specific geographic region. This provision also allows physicians to
give their patients greater access to vaccines that are available at
a local pharmacy and not available in the physician's office.

Another rationale for broadening the list of vaccines is that
pharmacist administration of vaccines is common across the country.
Medicare Part D allows pharmacies to submit claims for vaccines and


vaccine administration, moving adult immunization into the pharmacy
benefit. This provision is a national policy response to the need to
improve the rate of adult immunization consistent with the
recommendations of the Centers for Disease Control. Prevention is a
cost-containment tool as well as a public health goal.

In addition, more and more physician offices have limited their supply
of vaccines on hand due to cost, special handling requirements or
other reasons. Consider, for example, the herpes foster vaccine that
prevents shingles" (Shingles is a painful disease characterized by
inflammation of the nerve endings.) The target group for this
vaccination is adults 60 years of age or older. The vaccine must be
protected from light and stored in a freezer. It may be stored or
transported at 36 - 46 degrees Fahrenheit, but if it is, it must be
used within 72 hours. Stored improperly, the vaccine must destroyed.
Its cost is $200 per dose.

Whooping cough is an emerging public health concern in adults, having
caused several deaths in New York.
Adult immunization rates have traditionally been low and pharmacists
could under these new provisions would be authorized to administer
the one-time booster (TDap). TDap is recommended by the CDC for
adults. Other vaccines listed by the CDC recommended for adults are
varicella, HPV, measles, mumps and rubella, meningococcal, hepatitis
A and hepatitis B.

Entering the pharmacy profession today requires candidates to complete
a six-year program leading to the Doctor of Pharmacy degree.
Sixth-year pharmacy students are residents and interns in practice
sites that include
hospitals, clinics and community pharmacies, Those who have
successfully completed every requirement for certification as
immunizers represent an additional resource for broadening the
public's access to adult vaccines, and for this reason pharmacy
interns and residents should be allowed to administer under the
supervision of a licensed Pharmacist who holds a valid immunization
certificate and who has been authorized to administer specified
vaccines by a physician or nurse practitioner. Were an emergency
situation to arise, this provision in the bill increases the state's
preparedness assets.

It is appropriate that the $100 fee that pharmacists remit to the
education department with an application for the certificate of
administration becomes a one-time fee because department resources
are used to review the initial application and establish that the
applicant met all the requirements. Once a pharmacist has the
administration certificate, renewal should be automatic at the same
time the license is renewed, every three years, In addition, this
change in statute is consistent with policies of the department that
apply to other licensed health professions. In terms of public
protection, it is important to note that the Office of Professional
Discipline's authority includes revoking a pharmacist's certificate
of administration should such an action become necessary.

LEGISLATIVE HISTORY:
None.


FISCAL IMPLICATIONS:
None.

EFFECTIVE DATE:
This act shall take effect on the ninetieth day after
it shall have become law, with provisions.