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.
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
increase" means, based on past experience, an unforeseen change in the types,
urgency, or volume of sales, inquiries or requests specified in this rule.
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
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
An unexpected increase in:
(a) The number of prescriptions issued for
(b) The number of
prescriptions issued for medications to treat fever or respiratory or
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.
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.
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
(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.
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
of the Administrative Code.