Transcript immunization by pharmacists - New York State Council of Health

NYS PHARMACY BOARD UPDATE
May 8, 2010
Lawrence Mokhiber
David Flashover
Leigh Briscoe-Dwyer
IMMUNIZATION BY
PHARMACISTS
A real success story!
500,000
and a million doses administered
by NYS pharmacists
1,700 pharmacists certified
Rates of vaccination, especially among
minorities, significantly increased
IMMUNIZATION BY
PHARMACISTS
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What now?
Add new vaccinations?
 Amend record-keeping
requirements?
 Allow for administration of children
and adolescents?
 Allow for administration by
Pharmacy Interns
 Eliminate “sunset” of March 31,
2012
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IMMUNIZATION BY
PHARMACISTS

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

An unexpected concern?
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Very few graduating seniors are
applying for certification concurrent
with first license. Why??
Some pharmacists continue to avoid
involvement---their choice, of course,
but to what end?
Who among you is NOT certified and
would you mind sharing why?
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
NEW PENDING LEGISLATION
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A bill to allow pharmacists to access the
BNE data-base of filled prescriptions for
controlled substances.
Currently, only prescribers may access
this.
May assist in fighting
diversion/abuse/misuse of prescription
drugs
LEGISLATION NOT PASSED
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A bill to allow pharmacists and
physicians to choose to engage in
Collaborative Drug Therapy
Management (CDTM)
Where do we go----what can we do?
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Is there a “Plan B” option?
CITIZENSHIP
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Two possible resolutions--
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A lawsuit
Change in statute
Consider the paradox---politicians want
more multi-lingual counseling, and we
chase our most diverse pharmacists
away….
LEGISLATION NOT PASSED
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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
The sponsors are looking for support
and assistance from the profession
LEGISLATION NOT PASSED
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A bill to require the registration of Pharmacy
Technicians
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
LATEST DEVELOPMENT----OP/BOP ARE REDRAFTING A BILL TO MOVE THIS ISSUE.
INCLUDED WILL BE A REQUIREMENT THAT
PHARMACIES HIRE ONLY CERTIFIED TECHICIANS
AFTER A DATE-CERTAIN
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PHARMACY TECHNICIANS

Let’s see what we agree on:
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Minimum age?
Minimum education?
Standardized testing?
On-site or approved training?
Background check/finger-printing?
Certification v registration?
Disciplinary proceedings?
Fee?
WHAT DID 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;
effective 8/20/09
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---being prepared for presentation
to Regents---??July
Patient education a must!
We propose incorporating USP
standards
60-day expiration
 No controlled substances
 No chemically unstable, eg nitro
 Absolutely no return & re-use
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PROPOSED PAP 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
New Board members, including Ed Hayes--congrats Ed!
MEDICAL MARIJUANA
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An issue whose time has come?
Should this be considered as just
another drug, ie perhaps made as a
schedule II drug with all existing
provisions?
Should a whole, new distribution
system be developed? Who should
control
prescribing/dispensing/distribution?
OTHER ITEMS UNDER
CONSIDERATION
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Specific regulations regarding sterile
compounding
May include provisions now in USP
Chapter 797
EPT---Expedited Partner Therapy
Expedited Partner Therapy (EPT)
for chlamydia infections,
New York State, 2009
Chlamydia trachomatis (Ct)
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Most commonly reported Sexually
Transmitted Infection in nyc and in
US
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59,522 Ct cases reported, NYC, in 2009
15-25 year olds highly affected
Untreated Ct causes reproductive
tract scarring, chronic pelvic pain,
ectopic pregnancy, infertility
Treatment: 500 mg azithromycin po
X1
Chlamydia trachomatis (Ct)
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Each subsequent infection raises the risk of
these bad outcomes
Research has shown that:
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20% of cases reinfected within 1 yr
reinfection associated w/ partners not getting
treated
by giving meds to patients to give to their
partners (aka Expedited Partner Therapy) can
decrease reinfection rates
Expedited Partner Therapy (EPT)
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Endorsed by the Centers for Disease
Control and Prevention
Legal in 22 states
Legalized in NYS in 2009
Regulations drafted and in comment
period
NYS Regulations (Proposed)
Eligibility Criteria:
 To be used for partner(s) of a patient
diagnosed with Chlamydia trachomatis
(Ct) infection
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Patient with Ct cannot be concurrently
infected with gonorrhea or syphilis
Recommended EPT treatment:
 1 gm Azithromycin
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Packaged as single regimen
NYS Regulations (Proposed)
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Each patient and/or sexual partner
provided with EPT (medication or
prescription) must be given
educational materials
Educational materials will include:
 Medication instructions
 Potential adverse drug reactions,
including allergic reactions
 Possibility of interactions with other
medications
NYS Regulations (Proposed):
EPT Prescriptions
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When a health care practitioner provides
EPT through a prescription:
•
“EPT” must be written in the body of the
prescription form above the medication
name/dosage
•
“EPT” shall be sufficient to fill the
prescription if partner’s name, address,
and DOB are unknown
•
If known, partner’s name, address and
DOB should be included
NABP/AACP DISTRICT
MEETING
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On October 29-31, the New York
State Board of Pharmacy will host
the NABP/AACP District I and II
meeting at the Otesaga Hotel in
Cooperstown, NY. A very special
program is being developed. All are
welcome!
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]
On Facebook:NYSProfessions
www.op.nysed.gov