Legislative Update - Proposed Immunization Bill

Natalie Sims, ONU Pharm.D. Candidate, OPA Extern

In the U.S., over 5 million doses of influenza vaccine are administered annually in pharmacies. It should be encouraging to know that between 50 and 94 percent of patients who receive a pharmacist's recommendation to be immunized accept that recommendation. These statistics prove community pharmacists are in a vital position to combat vaccine-preventable diseases.

In 2000, the Ohio Pharmacists Association was instrumental in the passage of SB 248 (amending section 4729.41) which codifies the pharmacist's ability to administer the following adult immunizations: influenza, pneumonia, tetanus, hepatitis A and hepatitis B. Pharmacists desiring to give immunizations must:

1. complete a course in drug administration approved by the Ohio State Board of Pharmacy;
   
2. receive and maintain certification to perform basic life-support procedures by completing a basic life-support training course by the American Red Cross or the American Heart Association; and
   
3. practice in accordance with a definitive set of treatment guidelines specified in a protocol established by a physician and approved by the Ohio State Board of Pharmacy.

Changes in current Ohio law would enable pharmacists to broaden their influence during and beyond flu season, and make a widespread impact in preventing disease.

OPA lobbyists have met with Rep. Earl Martin (R-Avon Lake) to discuss sponsoring a bill to expand a pharmacist's abilities to provide immunizations in the community. There are five key components to be included in this bill.

1. Add diphtheria vaccine to the list of immunizations pharmacists are allowed to administer
   While tetanus toxoid is manufactured as a single entity product, it is not widely available or utilized. Commonly, it is combined with the diphtheria toxoid creating the Td vaccine. For patients seven years of age and older, the Td vaccine is recommended to be administered every 10 years to provide continued immunity against diphtheria and tetanus. The addition of the diphtheria toxoid to the list of immunizations in statute would allow pharmacists to increase vaccination rates in this area as well.
   
2. Add meningitis vaccine to the list of immunizations pharmacists are
   allowed to administer. This would also include lowering the age of "adult" to 14 to allow the meningitis vaccine to be given to the most appropriate age group (those 14- to 18-years-old).
   There are approximately 2,600 cases of meningococcal meningitis in the U.S. each year. In older children and adults, the meningitis vaccine is 85 to 100 percent effective at preventing infection from the strains used in the vaccine, and protection lasts for at least three years. Like the influenza and pneumococcal vaccines, the widespread use of the meningitis vaccine would significantly decrease the incidence of a preventable disease. Allowing pharmacists to administer the vaccine would widely increase the community's access to the vaccine.
   
   Children under two years of age have the highest incidence of meningitis, with a second peak incidence occurring between ages 15 and 24. Meningitis is often spread among those living in close contact with each other (e.g., at camps, colleges). Studies report that first-year college students living in dormitories have an elevated risk for meningococcal disease when compared with other undergraduate students. Ohio law requires students living in on-campus student housing at nonprofit institutions of higher education to disclose whether the student has been vaccinated against meningococcal meningitis (as well as hepatitis B). It would be helpful to have this vaccine easily available to these students in pharmacies.
   
3. Allow pharmacists to administer epinephrine and diphenhydramine
   State Board of Pharmacy rules state that protocols must address a method to handle emergency situations, such as allergic or anaphylactic reactions. Protocols may include the use of epinephrine and diphenhydramine. However, Ohio's pharmacy practice act does not currently include the administration of epinephrine and diphenhydramine by pharmacists. The critical time spent waiting for an authorized person to administer the medication may make the difference between life and death for the patient.
   
4. Expand the list of qualified professionals allowed to administer certain adult immunizations to include immunization-trained licensed pharmacy interns acting under the supervision of a licensed pharmacist who has been trained according to Ohio law
   Sixteen other states currently permit certified pharmacy interns to administer immunizations. The addition of pharmacy interns to the list of those permitted to administer immunizations would allow the interns the opportunity to obtain valuable practical experience while also helping to increase immunization rates in the community. Ohio's colleges of pharmacy are now including State Board- approved immunization training in their curricula.
   
5. Remove the requirement for pharmacists to notify the patient's primary care physician or local health department within 30 days after administering the immunization
   Pharmacy countertops and physicians' fax machines are bogged down with extra paperwork during the flu season. In Ohio, nurses who administer vaccines (including the influenza vaccine) are not required to submit the extra paperwork to the patient's physician or local health department, while pharmacists spend many hours at the fax machine. Physicians are in agreement with pharmacists that this is an unnecessary use of time and resources.
   
   What's Next?
   We have had preliminary meetings with the Ohio State Medical Association, and they have taken the above five key components back to their membership for feedback. We have reached agreement on the two most important issues, the addition of the meningitis and diphtheria vaccines to the list of immunizations pharmacists are allowed to administer, as well as allowing the administration of epinephrine and diphenhydramine for emergency situations pursuant to physician-approved protocols.
   
   Our next step is a joint meeting between interested parties which will take place before publication of this article. The meeting will include the Ohio State Medical Association, the Ohio Nurses Association, and the bill's sponsor, Rep. Earl Martin. We will continue to work together with the other interested parties to resolve our differences on the remaining issues. The sponsor will then distribute the draft language to all legislators to ask for co-sponsors. After the co-sponsors' list is complete, the bill will be introduced in the Ohio House of Representatives, and we will be on our way to not only making positive changes in the practice of pharmacy, but to making positive changes in the health of Ohio's citizens.