(A) As used in this rule:
(1) "Pharmacist" means an individual licensed under Chapter 4729. of the Revised Code to engage in the practice of pharmacy as a pharmacist.
(2) "Pharmacy," means the same as defined in division (A) of section 4729.01. of the Revised Code.
(3) "Prescription" means the same as defined in division (H) of section 4729.01. of the Revised Code.
(4) "Significant changes" means observations or occurrences of or related to medication usage that is, based on professional experience and judgment, too closely correlated to be attributed to chance.
(5) "Unexpected increase" means, based on past experience, an unforeseen change in the types, urgency, or volume of sales, inquiries or requests specified in this rule.
(B) All pharmacies and pharmacists shall immediately report information by telephone or electronically to the health commissioner of the health district having jurisdiction:
(1) Any prescription for medication used to treat a disease that is relatively uncommon and may have been caused by bioterrorism, or
(2) Significant changes in medication usage that may be caused by bioterrorism, epidemic or pandemic disease, or established or novel infectious agents or biological toxins posing a risk of human fatality or disability, or
(3) An unexpected increase in:
(a) The number of prescriptions issued for antibiotics;
(b) The number of prescriptions issued for medications to treat fever or respiratory or gastrointestinal complaints;
(c) The sales of or the number of requests for over-the-counter medication to treat fever, respiratory, or gastrointestinal complaints.
(C) Pharmacies and pharmacists shall submit reports required by this rule using forms and formats approved by the director. A pharmacy or pharmacist using an electronic reporting system or systems, to the extent approved by the director, is deemed to comply with the reporting requirements of this rule until such use is no longer considered active by the director.
(D) All health commissioners shall immediately report information received from pharmacies or pharmacists to the director.
(1) Health commissioner reports shall be submitted by telephone or by electronic means approved by the director.
(2) If a pharmacy has submitted an electronic report for over the counter medication sales as authorized by this rule and so advises the health commissioner, no further report is required.
(E) Upon receipt of a request from a health commissioner of the health district having jurisdiction, each pharmacy in the jurisdiction and for each location within the jurisdiction shall:
(1) Within ten business days of receiving such a request, identify an employee or employees of the pharmacy or a pharmacist or pharmacists employed at the pharmacy of who will be the point of contact for purposes of this rule.
(2) Within ten business days advise the health commissioner having jurisdiction of any change in the information of who will be responsible for being the point of contact for purposes of this rule.
(F) In consultation with the Ohio board of pharmacy, the director may publish a list of antibiotics and other medications that are required to be included in reports of significant changes in medication usage required by this rule.
(G) A pharmacy or pharmacist shall report information regarding events as specified in this rule. A pharmacy or pharmacist that does not report events in compliance with this rule is subject to an administrative fine as specified in rule 3701-73-02 of the Administrative Code.
Prior History: (R.C. 119.032 review dates:
Promulgated Under: 119.03
Statutory Authority: 3701.232
Rule Amplifies: 3701.232
Prior Effective Dates: 05/20/2005 )