Transcript immunization by pharmacists - New York State Council of Health

NYS PHARMACY BOARD UPDATE
May 3, 2009
IMMUNIZATION BY
PHARMACISTS
IT’S ABOUT TIME…
IMMUNIZATION BY
PHARMACISTS
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Bill passed as a result of a significant
collaborative effort of a large coalition
Bill signed into law on September 5,
2008; took effect December 5
Regulations were prepared and
adopted by the Board of Regents on
November 18 as an emergency
measure; about to become permanent
Bill “sunsets” March 31, 2012
What happens then?
IMMUNIZATION BY
PHARMACISTS
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What is required in the
law/regulations:
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Passage of a SED approved course. We
have chosen the APhA/CDC course
Completion of CPR/BLS
Hepatitis B Shot for self-protection
Note: Pharmacists will need to have an
NPI and apply to bill Medicare
IMMUNIZATION BY
PHARMACISTS
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To Become Certified, a pharmacist
must:
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Be currently registered
Have completed an approved course in
the past 3 years, including as an
undergrad
File an application with SED and pay a
fee of $100
IMMUNIZATION BY
PHARMACISTS
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To administer immunizations a pharmacist
may accept either a patient-specific order, or
a non patient-specific order from a physician
or a nurse practitioner. Such order must
include a protocol for the administration of
the immunizing agent and for use or drugs
to treat an emergency
Records of administration must be
maintained, either on a pharmacist’s
medication profile, or on another record
maintained in a retrievable format consistent
with current rules
IMMUNIZATION BY
PHARMACISTS
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Pharmacists will also be required to
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Counsel the patient and provide written
information as determined by DOH
Provide a patient with a record of the
immunization
Notify the primary care physician, if they are
known, of all patients immunized on a monthly
basis
Notify patients of the advisability of having a
primary care provider
Notify NYS and NYC Departments of Health
IMMUNIZATION BY
PHARMACISTS
Please go to our web site at site
www.op.nysed.gov for
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Additional information and a Q & A
Approved regulations
Application form
Links to training providers and related
information
IMMUNIZATION BY
PHARMACISTS
The Challenge!!!
o That at least one pharmacist per
registered pharmacy will become
certified, AND
 That Pharmacists will have a dramatic
effect on the reduction of preventable
illnesses
 This is NOT just a community pharmacy
issue!!!!!!!!!
OTHER LEGISLATION
PASSED IN 2008
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A requirement that every site at
which drugs (prescription and OTC)
are sold must post a sign informing
the public about the best way to
dispose of unused medications
LEGISLATION NOT PASSED
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A bill to allow pharmacists and
physicians to choose to engage in
Collaborative Drug Therapy
Management (CDTM)
Legislation to deter the introduction of
counterfeit drugs by employing, in
addition to other strategies, electronic
track and trace technologies
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Counterfeiting remains a serious concern
LEGISLATION NOT PASSED
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A bill to require the registration of Pharmacy
Technicians
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Bill would protect pharmacists/pharmacies by
screening support staff
Bill would define duties
Would allow SED/BOP to choose a certification
process, e.g. PTCB
Bill passed the Senate, but not acted upon in the
Assembly
LAWS v. REGULATONS
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The process is quite different.
When possible, the development of
regulations is simpler—though not
quick & easy
An agency must have authority to
develop regulations; Regulations
may not contradict laws
WHAT MIGHT WE ACHIEVE
BY REGULATIONS?
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Elimination of SED/Board of Pharmacy
requirements for hard-copy of records.
This proposal was presented to
the Board of Regents on 4/20/09;
potentially effective 8/20
HOWEVER---
Before scanning then discarding paper
copies, consider that DEA/BNE, Medicaid,
Medicare and others may have stricter
provisions. We intend to set a tone but
cannot compel others
PROPOSED REGULATION
CHANGES
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Multi-dose packaging, also
commonly called “Co-Mingling”
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This issue has been held up for a long
time--We propose incorporating USP
Standards
Controlled Substances will be Precluded
PROPOSED REGULATION
CHANGES
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A proposal to allow professionals to
use their pocket registration (picture
ID) cards in lieu of registration
certificates
PROPOSED REGULATION
CHANGES
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For those enrolled in an accredited
pharmacy practice residency, to allow
written attestation by the Program Director
of competency in sterile product
preparation and pharmacy practice in lieu of
Part III of the licensing examination series
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This proposal was presented to
the Board of Regents on April
20; potentially effective August
20, 2009. Letters of support
will be helpful.
PROPOSED REGULATION
CHANGES
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Expansion of the Professional Assistance
Program (PAP) to conform it to the model
that works well for nurses. The most
significant difference is reduced time of
“surrender” of a license, thus allowing us
to assist professionals before they hit
“rock bottom”
It is a very successful program that, we
think, can be made even better
TECHNICIAN REGISTRATION
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The Board of Pharmacy held a
special meeting on February 24,
2009 to obtain input from all
stakeholders. There was general
consensus on a number of points
Undecided—will this require
legislation or will we be able to do
in regulation
OTHER ITEMS UNDER
CONSIDERATION
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Specific regulations regarding sterile
compounding
May include provisions now in USP
Chapter 797
AUDIENCE PARTICIPATION!
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It has been suggested that we
should have clearer laws and
regulations defining practice in
different settings, e.g. hospital v.
community practice.
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Do you agree? If so, can you give
specific examples of what you would
like addressed?
LICENSURE EXAMINATIONS
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The Board of Pharmacy and the
Department worked to streamline
licensure and offered an incentive to
students to engage in voluntary
internship by allowing early
admission to Part III of the exam
series on a trial basis.
LICENSURE EXAMINATIONS
Students were allowed to sit for Part
III in January, 2009 if they had:
 Been certified as having been enrolled
in the final year of study, and
 Completed at least 1,000 hours of
internship (NOT required rotations) by
January 9, 2009
 Submitted an application and all
paperwork by November 1, 2008
LICENSURE EXAMINATIONS
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This proposal is similar to a concept
used in licensure of physicians
Is strictly voluntary
Has the potential to license new
graduates more quickly
Dispels certain “Urban Legends”
AND THEN WE HAVE
GUIDELINES….
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Currently, the Board of Pharmacy is
developing a guideline to define the
proper labeling of drugs dispensed
to inpatients and clinic/ER patients.
We should not destroy valuable
medications and we believe this
guideline will help reduce costs and
destruction of medications
THANK YOU!
How to contact us:
New York State Board of Pharmacy
89 Washington Avenue, 2nd Floor
Albany, NY 12234
518-474-3817 ext 130
[email protected]
www.op.nysed.gov