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NYS PHARMACY BOARD UPDATE May 8, 2010. Lawrence Mokhiber David Flashover Leigh Briscoe-Dwyer.

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Presentation on theme: "NYS PHARMACY BOARD UPDATE May 8, 2010. Lawrence Mokhiber David Flashover Leigh Briscoe-Dwyer."— Presentation transcript:

1 NYS PHARMACY BOARD UPDATE May 8, 2010

2 Lawrence Mokhiber David Flashover Leigh Briscoe-Dwyer

3 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

4 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

5 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

6 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?

7 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

8 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

9 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?

10 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….

11 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

12 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

13 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?

14 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

15 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

16 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!

17 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?

18 OTHER ITEMS UNDER CONSIDERATION  Specific regulations regarding sterile compounding  May include provisions now in USP Chapter 797  EPT---Expedited Partner Therapy

19 Expedited Partner Therapy (EPT) for chlamydia infections, New York State, 2009

20 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

21 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

22 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

23 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

24 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

25 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

26 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!

27 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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