Section 856 IAC 4-1-4 - Reporting of adverse eventsAuthority: IC 25-26-13-4; IC 25-26-13-31.5
Affected: IC 16-38-5-2; IC 25-26-13
Sec. 4.
(a) A pharmacist or pharmacist intern's supervising pharmacist shall report adverse events to the patient's primary care physician and the physician who approved the immunization protocol within seventy-two (72) hours of the pharmacist's knowledge of the adverse event.(b) A pharmacist or pharmacist intern's supervising pharmacist shall report to the Vaccine Adverse Events Reporting Systems, the cooperative program for vaccine safety of the Centers for Disease Control and Prevention and the Food and Drug Administration.(c) A pharmacist or designee shall report the immunization of each individual to the immunization data registry maintained by the state department of health under IC 16-38-5, unless a written immunization data exception form has been completed and filed in accordance with IC 16-38-5-2.(d) The qualifying pharmacist is responsible for ensuring that records of the reporting of adverse events is maintained by the pharmacy. Indiana Board of Pharmacy; 856 IAC 4-1-4; filed Dec 2, 2008, 4:03 p.m.: 20081231-IR-856070541FRA; filed Feb 21, 2014, 4:11 p.m.: 20140319-IR-856130449FRAReadopted filed 10/6/2020, 12:03 p.m.: 20201104-IR-856200443RFAReadopted filed 2/15/2024, 1:16 p.m.: 20240313-IR-856230795RFA