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Ohio News: Zoster Vaccine Approved
Published in the August 2009 Ohio State Board of Pharmacy Newsletter
Also on June 21, 2009, revised rules 4729-5-36 (course requirements in the administration of immunizations) and 4729-5-37 (protocols for the administration of immunizations) and new rule 4729-5-38 (immunization administration) became effective.
During the last legislative session, the law relating to pharmacists administering injections (§4729.41 ORC) was changed to allow the Board of Pharmacy to add drugs to the list of approved vaccines by rule. We have to do this in consultation with the State Medical Board of Ohio, but it is no longer necessary to ask the legislature to change the law every time a new drug needs to be added.
The first drug that the Board was requested to add was zoster vaccine. After consulting with the Medical Board on the proposed wording for the new rule, the Board was able to add this product to the list of immunizations that may be administered by a pharmacist.
After receiving proper training for zoster vaccine administration as outlined in rule 4729-5-36 and after obtaining a signed protocol pursuant to rule 4729-5-37, a pharmacist may now administer zoster vaccine to patients. Unlike the other approved products, however, zoster vaccine has some additional requirements to be met. The new rule reads as follows:
4729-5-38 Immunization administration:
In addition to the immunizations and medications listed in section 4729.41 of the Revised Code and pursuant to the requirements noted in section 4729.41 of the Revised Code and rules 4729-5-36 and 4729-5-37 of the Administrative Code, a pharmacist may administer the zoster vaccine according to the following requirements:
(A) The pharmacist must receive a patient specific prescription prior to administration of the drug;
(B) The vaccine must be administered within thirty days of the issuance of the prescription;
(C) The patient must meet the age criteria specified in the F.D.A. approved labeling; and
(D) The pharmacist must be able to document meeting the training criteria required by rule 4729-5-36.
As the rule states, a pharmacist must receive a prescription before administering zoster vaccine and then the vaccine administration must occur within 30 days from the date the prescription was written. If the drug is not administered within the 30-day window, the pharmacist must receive new authorization from the prescriber before administering the vaccine (ie, a new prescription or, at least, a verbal authorization to proceed, properly noted on the original prescription). The drug may not be administered to anyone under the age of 60 at this time, although that may change in the future, based on the Food and Drug Administration (FDA) labeling.
