IMMUNIZATION BY PHARMACISTS 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 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 To Become Certified, a pharmacist must: 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 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 Pharmacists will also be required to 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 www.op.nysed.gov 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 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 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 Counterfeiting remains a serious concern
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 Bill passed the Senate, but not acted upon in the Assembly
LAWS v. REGULATONS 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? 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 Multi-dose packaging, also commonly called “Co-Mingling” This issue has been held up for a long time--- We propose incorporating USP Standards Controlled Substances will be Precluded
PROPOSED REGULATION CHANGES A proposal to allow professionals to use their pocket registration (picture ID) cards in lieu of registration certificates
PROPOSED REGULATION CHANGES 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 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 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 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 Specific regulations regarding sterile compounding May include provisions now in USP Chapter 797
AUDIENCE PARTICIPATION! It has been suggested that we should have clearer laws and regulations defining practice in different settings, e.g. hospital v. community practice. Do you agree? If so, can you give specific examples of what you would like addressed?
LICENSURE EXAMINATIONS 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 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 …. 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, 2 nd Floor Albany, NY 12234 518-474-3817 ext 130 Pharmbd@mail.nysed.gov www.op.nysed.gov