(A) As used in this rule:
(1) "Customer" means a person located
in this state that orders or seeks to order a reported drug from an Ohio
licensed drug distributor and includes the following:
(a) A licensed terminal
distributor of dangerous drugs; or
(b) A prescriber who
possesses, or possesses for sale or sells, at retail, a dangerous
drug.
(2) "Prescriber" has the same meaning
as in section 4729.01 of the Revised Code.
(3) "Reported drug" means any dangerous
drug whose sale is required to be reported to the drug database pursuant to
agency 4729 of the Administrative Code.
(B) This rule only applies to the following drug distributors
licensed in accordance with section 4729.52 of the Revised Code:
(1) Wholesale distributors of dangerous
drugs;
(2) Virtual wholesalers;
(3) Manufacturers of dangerous drugs;
and
(4) Outsourcing facilities.
(C) Drug distributors listed in paragraph (B) of this rule shall
design and operate a system to identify and report suspicious orders by
customers for reported drugs. Suspicious orders shall include, but are not
limited to, the following:
(1) Orders of unusual size;
(2) Orders deviating substantially from a normal
pattern; and
(3) Orders of unusual frequency.
(D) Prior to any shipment of an order that a distributor has
identified as suspicious, two persons designated by the distributor's
responsible person must independently analyze the order. In order to proceed
with the shipment and complete the sale, each of the two persons must determine
that the order is not likely to be diverted from legitimate
channels.
(E) All suspicious orders, regardless of actual sale, shall be
submitted electronically in a manner and format determined by the board. The
electronic submission of suspicious orders shall include all information as
required by the board and shall be submitted within five days of the order
being identified as suspicious by the drug distributor.
(F) All drug distributors listed in paragraph (B) of this rule
shall submit a zero report, in a manner determined by the board, if no
suspicious orders have been identified by the distributor in a calendar month.
The zero report shall be submitted within fifteen days of the end of the
calendar month.
(G)
(1) Except as provided in paragraph (G)(2) of
this rule, a drug distributor listed in paragraph (B) of this rule shall
exercise due diligence to identify customers ordering or seeking to order
reported drugs to establish the normal and expected transactions conducted by
those persons and to identify and prevent the sale of reported drugs that are
likely to be diverted from legitimate channels. Such measures shall include,
but are not limited to, the following which shall to be conducted prior to an
initial sale and on an annual basis:
(a) Questionnaires and
affirmative steps by the drug distributor to confirm the accuracy and validity
of the information provided.
(b) For a customer who is a
prescriber, confirmation of prescriber type (physician, dentist, veterinarian,
etc.), specialty practice area (oncology, geriatrics, pain management, etc.)
and if the prescriber personally furnishes reported drugs and the quantity
personally furnished.
(c) Review of drug
utilization reports.
(d) Obtaining and
conducting a review of the following information:
(i) The methods of payment accepted (cash,
insurance, medicaid, medicare) and in what ratios;
(ii) The ratio of controlled vs. non-controlled
drug orders and overall sales;
(iii) Orders for reported drugs from other drug
distributors made available by the United States drug enforcement
administration's automation of reports and consolidated orders system;
and
(iv) The proportion of out-of-state patients
served compared to in-state patients.
(2) A drug distributor receiving a request for an
initial sale for a reported drug may conduct the sale without complying with
paragraph (G)(1) of this rule if all the following applies:
(a) The sale is to an
institutional facility as defined in agency 4729 of the Revised Code that is a
new customer of the distributor;
(b) The drug distributor
documents that the order is to meet an emergent need; and
(c) The drug distributor
completes the requirements set forth in paragraph (G)(1) of the rule no later
than sixty days from the date of sale.
(H) Any customer that may be engaging in possible activities that
may cause reported drugs to be diverted from legitimate channels, including
those to whom a drug distributor refuses to sell, shall be electronically
reported by the drug distributor in a manner and format determined by the
board. The electronic submission of such customers shall include all
information as required by the board and shall be submitted within five days of
refusal, cessation or identification by the drug distributor.
(I) Within ninety days of the effective date of this rule, a drug
distributor shall provide, in a manner and format determined by the board,
information on all customers in this state the distributor has refused to sell
to or has stopped selling to within the past three years because the
distributor has identified the customer as engaging in possible activities that
may cause reported drugs to be diverted from legitimate channels. The
submission of information shall contain the customer's name, address, drug
enforcement administration registration (if applicable), terminal distributor
of dangerous drugs license number (if applicable), and a detailed explanation
of why the distributor identified the customer as a possible diversion
risk.
(J) All drug distributors described in paragraph (A) of this rule
shall maintain and implement policies and procedures that include all the
following:
(1) The design and operation of a suspicious
order monitoring and reporting system.
(2) A system to collect the necessary information
on customers in accordance with paragraph (G) of this rule.
(3) Mandatory training, to be conducted annually,
for staff responsible for the processing of all orders for reported drugs that
includes all the following:
(a) The drug
distributor's suspicious order monitoring system;
(b) The process to collect
all relevant information on customers in accordance with paragraph (G) of this
rule;
(c) The process for
submission of suspicious orders and customers who may be engaging in possible
activities that may cause reported drugs to be diverted from legitimate
channels to the board; and
(d) Information on
submitting a confidential report of a suspicious order or customer engaging in
possible activities that may cause reported drugs to be diverted from
legitimate channels by using the board's online electronic complaint form
that can accessed by visiting: www.pharmacy.ohio.gov. The training shall remind
all employees that complaints and all information submitted that identifies a
complainant shall remain confidential pursuant to section 4729.23 of the
Revised Code.
(K) All policies and procedures maintained in accordance with
paragraph (J) of this rule shall be reviewed and updated on an annual
basis.
