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NYS PHARMACY BOARD UPDATE May 8, 2010
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Lawrence Mokhiber David Flashover Leigh Briscoe-Dwyer
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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
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IMMUNIZATION BY PHARMACISTS 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: 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
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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?
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IMMUNIZATION BY PHARMACISTS Please go to our web site at site www.op.nysed.gov for www.op.nysed.gov Additional information and a Q & A Approved regulations Application form Links to training providers and related information
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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
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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?
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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….
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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
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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. PTCB LATEST 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
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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?
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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
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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
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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!
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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?
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OTHER ITEMS UNDER CONSIDERATION Specific regulations regarding sterile compounding May include provisions now in USP Chapter 797 EPT---Expedited Partner Therapy
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Expedited Partner Therapy (EPT) for chlamydia infections, New York State, 2009
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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
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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
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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
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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
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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
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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
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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!
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THANK YOU! How to contact us: New York State Board of Pharmacy 89 Washington Avenue, 2 nd Floor Albany, NY 12234 518-474-3817 ext 130 Pharmbd@mail.nysed.gov On Facebook:NYSProfessions www.op.nysed.gov
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