On November 10th, the FDA approved lowering the age requirements for CSL Limited's inactivated influenza vaccine. Formerly, the manufacturer's H1N1 vaccines were restricted to patients age 18 and up; however, the new rules allow for patients age 6 months and up to be vaccinated. In addition, the FDA approved ID Biomedical Corporation, a manufacturing company owned by GlaxoSmithKline, for the production of injectable H1N1 Influenza vaccine. Currently, the manufacturer's Influenza vaccine will be given only to patients age 18 and up.
The Ohio Pharmacists Association has written draft adult immunization protocols for H1N1 vaccines in compliance with the Ohio State Board of Pharmacy's rule 4729-5-37. We have drafted protocols for the intranasal and the injectable forms of H1N1 vaccines, as well as an H1N1 immunization administration record.
H1N1 Influenza Administration Record 11.09
H1N1 Influenza Immunization Protocol 11.09.pdf
H1N1 Intranasal Influenza Immunization Protocol 9_09
CDC's website below includes VIS statements for both H1N1 vaccines: http://www.cdc.gov/vaccines/pubs/vis/default.htm.
Each physician-established protocol must follow Ohio Statute (Division (B)(3) of Section 4729.41 of the Revised Code) and the State Board rule mentioned above. These protocols were designed to be used by pharmacists who intend to administer immunizations, and who have successfully completed a course in the administration of adult immunizations that has been approved by the State Board of Pharmacy and who are certified in basic life-support by the American Red Cross or the American Heart Association.
Each protocol must be renewed with the physician annually. Any changes must be in accordance with the State Board rules mentioned above.
We would appreciate any feedback, comments or suggestions.