Expanding Immunizing Pharmacist Services in North Carolina

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Expanding Immunizing Pharmacist Services in North Carolina Ryan Swanson, Pharm.D. Clinical Coordinator Kerr Drug/Kerr Health September 23, 2010 Financial Disclosure No relevant financial relationships with any commercial interests to disclose Objectives Discuss the current state of immunizing pharmacist services in North Carolina Discuss efforts of NCAP s Immunization Task Force to expand these existing services

Who is NCAP? North Carolina Association of Pharmacists Reorganized as an integrated association in 2000 Sole statewide professional pharmacy association in NC Mission is to unite, serve, and advance the profession of pharmacy in the state 2,000+ members Pharmacists, student pharmacists, and pharmacy technicians History of the Task Force Formed in July 2009 In response to multiple separate inquiries from NC pharmacists about expanding immunizing services in the state NCAP viewed as a natural choice to mobilize such an effort Task Force Members Recruited through two methods E-mail blast to NCAP membership Specific requests to NC pharmacists identified as immunization experts 13 members Community pharmacists Academic pharmacists Board of Pharmacy representative Previous work histories include hospital, ambulatory care, and industry practices

First Things First Questions with which our Task Force began Where does NC currently stand? Do pharmacists have a role beyond what is currently authorized? How does this compare to the other 49 states? Vaccination Privileges in NC Pharmacists must follow a written order, standing medical order, or other protocol under a licensed M.D. or D.O. for administration of influenza, pneumococcal, and zoster vaccines. Vaccinations may only be administered to patients 18 and older.* The pharmacist must consult with a patient s primary care provider prior to administering the pneumococcal or zoster vaccines. If the patient has no PCP, these vaccines may not be administered. *A (Short-Lived) Exception NC emergency amendment Effective October 9, 2009, pharmacists will have temporary authority to administer seasonal and H1N1 flu vaccine to patients age 14 and older. Note that authority was temporary Extended until July 2010

NC Emergency Amendment Still some confusion among pharmacists about this temporary authority On Sept. 9, NC Board of Pharmacy reiterated on its website: The Board office has received several calls from pharmacists regarding 21 NCAC 46.2507. Pharmacists are reminded that the temporary authority to administer the influenza vaccine to patients between ages 14 and 18 expired in July 2010. Therefore, as is stated in rule.2507c(5), pharmacists shall not administer vaccines to patients under 18 years of age. Immunizing Pharmacists Can Make A Difference An analysis of data collected between 1995-1999 Rates of influenza vaccination among older adults were significantly higher in states where pharmacists were permitted to vaccinate compared with those where they were not Steyer TE, et al. Vaccine. 2004;22(8):1001-1006. Immunizing Pharmacists Can Make A Difference Survey of 1,730 patients vaccinated in a community pharmacy 84% of respondents thought the pharmacy was more accessible 99% of respondents would recommend vaccination in a pharmacy to others Grabenstein JD, et al. J Am Pharm Assoc. 2001;41(1):46-52

More Work To Be Done Vaccination rates in adults Vaccination Vaccination Rates Influenza (50-64 y/o) 42.2 Influenza (65 y/o) 68.8 Pneumococcal (65 y/o) 65.6 Tetanus in past 10 years (18-64 y/o) 57.2 Tdap in past 2 years (18-64 y/o) 2.1 Zoster vaccine ( 60 y/o) 1.9 National Immunization Survey Adult; 2007. The Bottom Line Vaccination rates are not where they need to be In both the U.S. and NC Among all age groups Pharmacists remain the single-most accessible healthcare providers. Expansion of immunizing services is a golden opportunity to expand the practice of pharmacy while meeting a true public health need. Goals of the Task Force 1. Broaden scope of immunizations that NC pharmacists may administer Open protocol rule is ideal 2. Lower age limit for patients receiving immunizations from NC pharmacists How low can we go? How low should we go?

1. Broadening the Scope of Immunizations Extent of Pharmacist Immunization Administration Authority Full/Nearly Full Gives pharmacists full or nearly full authority to administer any vaccine to patients of any age via any route of administration under a protocol or standing order Partial/Limited Gives pharmacists only partial or limited authority to administer vaccines by Requiring a patient-specific prescription Restricting the types of vaccines Restricting the patient s age Or other significant restrictions

Extent of Pharmacist Immunization Administration Authority Number of States Extent of Administration Authority State Law Highlights Currently, 17 states provide full or nearly full (i.e., open protocol ) authority to pharmacists AL, AK, CA, CO, ID, ME, MI, MS, NE, NV, OR, SC, TN, TX, VT, VA, and WA 2. Lowering the Current Age Limit

Pharmacist Authority to Administer Influenza Vaccine: Age of Patient Limitations American Pharmacists Association, September 2009. Patient Age Limitations On Pharmacist Vaccination Rights Age Restriction Number of States Any 19 18 16 14 13 11 Exceptions 17 (AL, AK, CA, CO, ID, MI, MS, MO, NE, NV, NH, NM, OK, SC, TN, TX, WA) 1 (WY) 21 (AZ, AR, CT, DE, FL, HI, IA, KS, MA, MT, MD, NC, ND, NJ, NY, PA, RI, SD, VT, WS, WV) 1 (LA) 2 (IL, IN) 1 (UT) 1 (OR) 6 (OH, GA, KY, ME, MN, VA) State Law Highlights Ohio 14 for influenza, 18 for all other vaccines Kentucky 18 years of age for protocols, any age by Rx Maine 9 for influenza, 18 for all other vaccines Minnesota 10 for influenza, 18 for all other vaccines

Rationale for Various Age Limits 14 years A precedent for this age has already been set with the emergency rule 9 years Certain vaccinations require multiple injections prior to age 9 (e.g., influenza) Minimum age for HPV 7 years CDC s adolescent immunization schedule begins at this age Task Force Actions to Date Initial meeting of the Immunization Task Force Identified and prioritized goals and objectives Meetings with various interested parties to gauge potential support/pushback North Carolina Board of Pharmacy American Pharmacists Association NC Immunization Branch NC Board of Medicine NC Pediatric Society NC Academy of Family Physicians NC Board of Nursing NC Association of Nurses Department of Public Health Task Force Actions to Date Survey of the NC pharmacist community to gauge its willingness to support these efforts 13-question survey created with SurveyMonkey, a web-based survey-development tool Distributed by the NC Board of Pharmacy Link to survey e-mailed to all actively registered pharmacists residing in NC with e-mail addresses on file with the BOP Sent to 9,619 e-mail addresses 129 e-mails bounced back 9,490 pharmacists received survey 952 responses (10%)

Survey Results Survey Results (2) Survey Results (3)

Survey Results (4) Survey Results (5) Survey Results (6)

Survey Results (7) Survey Results (8) Survey Results (9)

Survey Results (10) Survey Results (11) Non-Vaccine Injectables Pharmacists currently not authorized to administer non-vaccine injectable medications to patients in NC E.g., Depo-Provera, Lovenox, Vitamin B12, etc. Anecdotal evidence that expansion of RPh administration authority into this arena may not be as controversial as vaccines

Survey Results (12) Additional Comments/Concerns from Question #12 Comment Category # Comments Training for pharmacists (more training, more CE, practice admin. of 53 vaccine) Liability issues 40 Time constraints (especially in chain retail setting) 35 Documentation/tracking of vaccinations 22 Subcategory: National database availability 3 Safety of administering/emergency protocols 21 Staff (adequate staff, staff dedicated to immunizations only) 15 Communication with MD 12 Subcategory: Patient history not available 3 Subcategory: Physician willingness for open protocol 4 Within scope of pharmacy practice 12 Out of scope of pharmacy practice 7 Reimbursement of pharmacists 7 Vaccinating pediatrics (against) 7 Prescription from MD to administer vaccine (not open protocol ) 6 Space/privacy limitations 5 Choice of the individual pharmacist to vaccinate (protect against chain 4 mandates) Stock/storage of vaccines 2 Patient out-of-pocket expenses (covered at physician office but not at 1 pharmacy) HPV vaccine (<18 yo, okay for 14 yo to consent without parent?) 1 Survey Results (13)

Additional Comments/Concerns from Question #13 Comment Category # Comments Liability (insurance, autism controversy, etc.) 29 Need for pediatrician (regular peds vaccines, continuity of care, wellchild visit, etc.) 25 Requirement for additional training 22 Possibility of ADR or allergy to vaccine 21 Children disliking vaccines/causing problems in public setting/too much trouble 16 Recordkeeping too time-consuming or impossible in community setting 9 Privacy problems in current setting 8 Time constraints for practice 7 Which Path to Expanded Authority? Ultimately, we had to make a choice between: 1. Legislative route Short session began May 12, 2010 Typical short session last weeks (rather than months) Legislation introduced during this period must be budgetneutral Same rules will not apply during the long session (2011) 2. Rule-change route Boards of Pharmacy, Medicine, and Nursing must all agree to rule change Both routes had their own set of challenges But was there a lesser of two evils? Where We re Headed Decision has been made to pursue our efforts via the legislative route First and second drafts of our proposal have been circulated to key stakeholders Initial proposal included three major changes to the current rule: 1. Authorize immunizing RPhs to administer all vaccines 2. Authorize immunizing RPhs to adminster vaccines to patients aged 7 and older 3. Authorize immunizing RPhs to administer nonvaccine injectable medications

Non-Vaccine Injectables Considerable support within the pharmacy community for this initiative And some support among other health professions However, this element of the proposal has been eliminated Our conversations with various stakeholders proved that this issue seemed only to muddy the waters of expanding immunizing authority Next Steps Presentation this fall before Joint Legislative Health Care Oversight Committee Meet with final groups of key stakeholders NC Hospital Association, AMA Solidify language for proposed legislation BUCKLE UP! Contact Information: Questions? Ryan Swanson, Pharm.D. Kerr Drug Community Healthcare Center Sanford, NC rswanson@kerrhealth.com (919) 776-4107