Legislative Update April 2006
Pharmacist Immunization, Pharmacy Freedom of Access, Drug Compounding Licensing
Kelly Vyzral, Director of Government Affairs
HB 524: Pharmacist Immunization (Martin)
This legislation will expand the Pharmacy Practice Act to:
1. include diphtheria, pertussis and meningitis in the list of adult immunizations pharmacists are allowed to administer;
2. allow pharmacists to administer the influenza vaccine to those 14 years and older;
3. allow pharmacists to administer epinephrine and diphenhydramine in the event of an anaphylactic reaction;
4. expand the list of qualified professionals able to administer vaccinations to include trained pharmacy interns acting under the direct supervision of trained licensed pharmacists;
5. remove the requirement for pharmacists to notify the patient's primary care physician or local health department within 30 days after providing the influenza immunization.
HB 524 has had two hearings in which the House Health Committee heard testimony from the sponsor, Rep. Earl Martin, that the bill would increase access to immunizations. The committee also heard proponent testimony from Randy Wexler, M.D., Chet Kaczor, a pharmacy student from Ohio Northern University, and Don Bennett, R.Ph., MBA. We are hopeful that the bill will be voted out of the House Health Committee soon.
Pharmacy Freedom of Access
Rep. Tom Patton has agreed to sponsor Any Willing Pharmacy legislation that would allow nonparticipating pharmacies to fill prescriptions if they would accept the same terms and conditions. It will require equal co-pays, equal days' supply, and open access. The bill is currently being drafted. OPA will update you with more information when the bill is introduced.
Pharmacy Freedom of Access legislation will:
a. prohibit insurance companies from excluding providers of pharmacy services who want to accept the managed care participation requirements;
b. enhance patient choice of pharmacy service providers;
c. protect patients from economic penalties;
d. assure patients in rural communities greater access to local pharmacists within communities.
Pharmacy Freedom of Access legislation will not:
a. interfere with an insurance company's ability to utilize traditional managed care concepts including benefit design, patient fee schedules, quality standards and utilization review requirements;
b. cause health insurance premiums to increase.
Thirty-three other states already have an any willing provider for pharmacy services provision in place without seeing an increase in healthcare premiums. We see this bill as critical to pharmacy now that most pharmacies' business in Ohio is controlled by third-party payers.
Donating Drugs to Colleges and Schools of Pharmacy
Rep. Shawn Webster has agreed to sponsor legislation that would allow colleges and schools of pharmacy to accept donated and expired drugs for instructional purposes. The donated drugs would come from pharmacies, wholesalers and manufacturers. The idea for this legislation was brought to us by pharmacists on faculty at a couple of the colleges in Ohio. The cost of purchasing drugs that are used for instructional purposes has become a big concern for Ohio's colleges and schools of pharmacy as higher education funding from the State keeps dwindling.
H.B. 542: Drug Compounding Licensing
(Fende) This bill is the companion legislation to SB 188 that was introduced in the Senate by Senator Tim Grendell. The bill would create a license issued by the Board of Pharmacy authorizing a terminal distributor to compound drugs, on a routine basis, and sell those drugs to an authorized prescriber of drugs. It also provides that a terminal distributor compounding license is valid for one year and requires the Board to review and renew licenses.
This license allows the compounder to:
a. compound a drug that is not commercially available;
b. provide the drug to a licensed health professional authorized to prescribe drugs who orders the drugs without a patient-specific prescription for direct administration to patient;
c. compound and provide the drug on a routine basis pursuant to such orders.
In addition, the holder of this license is not subject to provisions specifying that a drug is to be compounded and provided as an occasional exception to the normal practice of dispensing drugs pursuant to a patient specific prescription.
This license exempts physicians who are incorporated from having to be licensed as terminal distributors. At any one time, compounders can only supply the lesser of 100 vials or a 30-day supply.
Compounders can only provide the drug on receipt of an order by writing, telephone or electronic means.
Prior to receiving the order, the compounder may compound the drug in anticipation of orders based on regular dispensing patterns. The Board of Pharmacy has asked for a written opinion from FDA on the provisions allowing for compounding for manufacturing without applying for an FDA license. The Board opposes the provision in the bill which exempts physicians who are incorporated from having to be licensed as terminal distributors. OPA will be following this bill closely.
If you have any questions or comments about the issues mentioned in this article, please contact Kelly Vyzral, Director of Government Affairs, at 614.586.1497 or email@example.com.
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