NYS PHARMACY BOARD UPDATEMay 8, 2010

Lawrence MokhiberDavid Flashover

Leigh Briscoe-Dwyer

IMMUNIZATION BY PHARMACISTS

A real success story! 500,000 and a million doses administered by NYS pharmacists 1,700 pharmacists certifiedRates of vaccination, especially among minorities, significantly increased

IMMUNIZATION BY PHARMACISTS

What now?Add new vaccinations?Amend record-keeping

requirements?Allow for administration of children

and adolescents?Allow for administration by

Pharmacy InternsEliminate “sunset” of March 31,

2012

IMMUNIZATION BY PHARMACISTS

What is required in the law/regulations: 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? 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 Additional information and a Q & A Approved regulations Application form Links to training providers and related

information

NEW PENDING LEGISLATION

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

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? Is there a “Plan B” option?

CITIZENSHIP

Two possible resolutions--- 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

Legislation to deter the introduction of counterfeit drugs by employing, in addition to other strategies, electronic track and trace technologies Counterfeiting remains a serious

concern The sponsors are looking for support

and assistance from the profession

LEGISLATION NOT PASSED

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. PTCBLATEST DEVELOPMENT----OP/BOP ARE RE-DRAFTING

A BILL TO MOVE THIS ISSUE. INCLUDED WILL BE A REQUIREMENT THAT PHARMACIES HIRE ONLY CERTIFIED TECHICIANS AFTER A DATE-CERTAIN

PHARMACY TECHNICIANS

Let’s see what we agree on: 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?

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

Multi-dose packaging, also commonly called “Co-Mingling” 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

PROPOSED PAP CHANGES

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

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

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)

Most commonly reported Sexually Transmitted Infection in nyc and in US 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 X 1

Chlamydia trachomatis (Ct) Each subsequent infection raises the risk of

these bad outcomes Research has shown that:

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)

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

Patient with Ct cannot be concurrently infected with gonorrhea or syphilis

Recommended EPT treatment: 1 gm Azithromycin

Packaged as single regimen

NYS Regulations (Proposed)

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

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

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 Pharmacy89 Washington Avenue, 2nd Floor

Albany, NY 12234518-474-3817 ext 130

Pharmbd@mail.nysed.govOn Facebook:NYSProfessions

www.op.nysed.gov