Ohio Admin. Code 4729:6-3-05 - Suspicious order monitoring and due diligence
(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.
Notes
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 4729.25, 4729.23, 4729.52
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