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Opioids to Minors and Drug Donation Programs

Objectives

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By completing the lesson, the pharmacist will be able to:

Discuss Ohios new laws concerning use of opioids in minors

Describe the documents and record keeping for opioid prescriptions
Discuss Ohios donated drug repository program
Describe record keeping for drug repository program
Introduction

As pharmacists, we are aware that prescriptions for children receiving opioid analgesics require
special attention. Ohio recently enacted new laws concerning use of opioid analgesics. While
most of the burdens fall on the prescriber, pharmacists need to be aware of these changes to
address questions about the law and understand the requirements. Ohio law also provides for
donation of prescription drugs to treat economically disadvantaged persons. While these
medications are in some sense free they come with record keeping requirements to assure
medication integrity. This lesson will discuss the law in these subjects.

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Prescribing of Opioids to Minors

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The U.S. Food and Drug Administration approved OxyContin for children as young as eleven
(11) years old on August 13, 2015. http://www.fda.gov/drugs/newsevents/ucm456973.htm. The
use of OxyContin among children is not something new. However the rules directed to
prescribing of opioids to minors are relatively new revisions to Ohio law. ORC 3719.061. The
law creates a duty on the prescriber to do certain things before issuing to a minor the first
prescription in a single course of treatment with an opioid analgesic:

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As part of the prescriber's examination of the minor, assess whether the minor has ever
suffered, or is currently suffering, from mental health or substance abuse disorders and
whether the minor has taken or is currently taking prescription drugs for treatment of
those disorders; ORC 3719.061 (B) (1)
Discuss with the minor and the minor's parent, guardian, or another adult authorized to
consent to the minor's medical treatment all of the following: ORC 3719.061 (B) (2)
o The risks of addiction and overdose associated with opioid analgesics; ORC
3719.061 (B) (2) (a)
o The increased risk of addiction to controlled substances of individuals suffering
from both mental and substance abuse disorders; ORC 3719.061 (B) (2) (b)
o The dangers of taking opioid analgesics with benzodiazepines, alcohol, or other
central nervous system depressants; ORC 3719.061 (B) (2) (c)
o Any other information in the patient counseling information section of the
labeling for the opioid analgesic required under 21 C.F.R. 201.57(c)(18). ORC
3719.061 (B) (2) (d).

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Note: 21 C.F.R. 201.57(c)(18) is directed to information necessary for

patients to use a drug safely and effectively (e.g., precautions concerning
driving or the concomitant use of other substances that may have harmful
additive effects).
The prescriber must also obtain written consent for the prescription from the minor's
parent, guardian, or, subject to division (E) of this section, another adult authorized to
consent to the minor's medical treatment. ORC 3719.061 (B) (3).
The prescriber must also record this consent on a form, known as the "Start Talking!"
consent form. ORC 3719.061 (B) (3). This form must be separate from any other
document the prescriber uses to obtain informed consent for other treatment provided to
the minor. The form must contain all of the following:
o The name and quantity of the opioid analgesic being prescribed and the amount of
the initial dose; ORC 3719.061 (B) (3) (a)
o A statement indicating that a controlled substance is a drug or other substance that
the United States drug enforcement administration has identified as having a
potential for abuse; ORC 3719.061 (B) (3) (b)
o A statement certifying that the prescriber discussed with the minor and the
minor's parent, guardian, or another adult authorized to consent to the minor's
medical treatment the matters described in ORC 3719.061 (B) (2); ORC 3719.061
(B) (3) (c)
o The number of refills, if any, authorized by the prescription; ORC 3719.061 (B)
(3) (d)
o The signature of the minor's parent, guardian, or another adult authorized to
consent to the minor's medical treatment and the date of signing. ORC 3719.061
(B) (3) (e)
Exemptions. The prescriber does not need to have the discussion or obtain the form
in the following scenarios:
o The treatment is associated with or incident to a medical emergency. ORC
3719.061 (C) (1) (a)
o The treatment is associated with or incident to surgery, regardless of whether the
surgery is performed on an inpatient or outpatient basis. ORC 3719.061 (C) (1)
(b)
o In the prescriber's professional judgment, fulfilling the requirements of division
(B) of this section with respect to the minor's treatment would be a detriment to
the minor's health or safety. ORC 3719.061 (C) (1) (c)
o The treatment is rendered in a hospital, emergency facility, ambulatory surgical
facility, nursing home, pediatric respite care program, residential care facility,
freestanding rehabilitation facility, or similar institutional facility. ORC 3719.061
(C) (1) (d)

Note: The discussion and form ARE NEEDED when the minor is treated
in a prescriber's office, even if located on the premises of, or adjacent to, a
hospital, emergency facility, ambulatory surgical facility, nursing home,

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pediatric respite care program, residential care facility, freestanding

rehabilitation facility, or similar institutional facility. ORC 3719.061 (D)
Limits. No more than a seventy-two (72) hour supply of a controlled substance
containing an opioid may be prescribed when another adult authorized by the minor's
parent or guardian gives the required consent. ORC 3719.061 (E). For example, if the
parents give written authorization to consent to medical treatment to a childs Aunt, the
prescriber can prescribe no more than a seventy-two (72) hour supply of hydrocodone for
the child when the Aunt takes the child for treatment. The Aunt has less authority to
consent than the parent or custodial guardian.
The Start Talking! form must be maintained in the minors medical record. ORC
3719.061 (F).

Defined as an opioid analgesic as of March 2015. ORC 3719.01

Generic Name
Buprenorphine
Butorphanol
Codeine (acetaminophen
and other combination
products)
Dihydrocodeine/ASA/caffei
ne
Fentanyl

Hydrocodone
Hydrocodone
(acetaminophen
combination products)
Hydrocodone (ibuprofen
combination products)
Hydromorphone
Meperidine
Methadone
Morphine Sulfate

Oxycodone
Oxycodone (acetaminophen,
aspirin and other
combination products)
Oxymorphone
Tapentadol
Tramadol

Brand Name
BUTRANS, BUPRENEX
BUTORPHANOL NS
TYLENOL W. CODEINE #3, TYLENOL W.
CODEINE #4

Schedule
Schedule III
Schedule IV
Schedule III

SYNALGOS-DC

Schedule III

DURAGESIC, ACTIQ, ABSTRAL,

LAZANDA, FENTORA, SUBSYS,
SUBLIMAZE, ONSOLIS, IONSYS
ZOHYDRO ER
XODOL, MAXIDONE, ZYDONE, LORCET,
HYCET, ZAMICET, CO-GESIC, ZOLVIT,
STAGESIC, LIQUICET, LORTAB, VICODIN,
NORCO
IBUDONE, REPREXAIN, VICOPROFEN

Schedule II

DILAUDID, EXALGO
DEMEROL
DOLOPHINE, METHADOSE
MS CONTIN, AVINZA, DURAMORPH,
KADIAN, DEPODUR, ASTRAMORPH,
IMFUMORPH
OXECTA, ROXICODONE, OXYCONTIN
PERCODAN, PERCOCET, ROXICET,
ENDOCET, XOLOX, TYLOX, PRIMLEV,
MAGNACET, XARTEMIS XR
OPANA, NUMORPHAN
NUCYNTA
ULTRAM, ULTRACET, RYZOLT, CONZIP,
RYBIX

Schedule II
Schedule II
(October 6, 2014)

Schedule II
Schedule II
Schedule II
Schedule II
Schedule II

Schedule II
Schedule II

Schedule II
Schedule II
Schedule IV
(August 18, 2014)

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Role of the Pharmacist

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Of course, the pharmacist should always use professional judgment before dispensing any
medication, particularly controlled substances. Some common sense points for the pharmacist to
keep in mind include:

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Pharmacists should be prepared to assure parents of young patients that presenting a copy
of the Start Talking! form to the pharmacist is not legally required to fill a legitimate
prescription.
Pharmacists should be prepared to communicate that the form is an important part of the
education process for proper use of opioids.
Pediatric patients with legitimate prescriptions should be treated with the same
compassion as any other patient.
Untreated pain is a problem just as much as drug abuse is a problem.
Under-treated pain is a problem just as much as drug abuse is a problem.
Exaggerated fears of addiction should not interfere with the proper evaluation and
treatment of pain.
If the pharmacist believes that the patient and the caregiver were somehow not included
in a discussion with the prescriber about proper use of opioids, the pharmacist should
consider an appropriate discussion of:
o The risks of addiction and overdose associated with opioid analgesics
o The increased risk of addiction to controlled substances of individuals suffering
from either mental and substance abuse disorders
o The dangers of taking opioid analgesics with benzodiazepines, alcohol, or other
central nervous system depressants
o Any other information necessary for patients to use the medication safely and
effectively (e.g., precautions concerning driving or drug interactions, and the like)

Though the new record keeping requirements create tasks to be performed by prescribers, the
pharmacist should note red flags which could indicate diversion:

Patients or caregivers travelling extremely long distances to have a prescription filled.

Most prescriptions will be filled nearby a prescribers office, the patients or caregivers
residence, or a caregivers place of work.
Very high doses of opioids being prescribed for young patients. Though pediatric
patients develop tolerance like any patient, comparatively smaller body weights of
pediatric patients are also to be considered.
Opiates being prescribed for very young patients for very long periods of time. There
are, of course, some children afflicted with conditions traditionally associated with adults.
The pain and suffering of children should be treated appropriately and not ignored.
A disproportionate number of prescriptions coming from one prescriber. Unless the
prescriber has a very specialized practice, the quantity of opioid prescription from any
given prescriber should be fairly similar to colleagues in that type of practice.

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Prescribers issuing prescriptions that may be outside of their scope of practice. The
pharmacist may expect that a specialist, such as a pediatric oncologist, might prescribe
more opioids for children than a cardiologist.

Drug Repository Program for Donated Prescription Drugs

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Community pharmacists are well aware of the economic pressure in daily practice. It would be
rare indeed for the pharmacist not to have some sort of discussion with a patient about
prescription drug costs every day. While they are not the solution for everybody, free clinics
have a role to play in assisting patients. Information about free clinics and their locations may be
found online at:

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http://ohiofreeclinics.org/
http://ohiofreeclinics.org/who-we-are/locations/find-a-clinic.html

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The Ohio State Legislature has established a drug repository program for donated prescription
drugs. ORC 3715.87. The purpose of the program is to provide medication to be dispensed to
individuals who are residents of Ohio and meet eligibility standards established in rules adopted
by the Board. Basically, the recipient must have no reasonable financial means to pay for the
drug prescribed and be a patient of a nonprofit clinic. OAC 4729-35-05 (B) (1) and 4729-3505 (B) (2).

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Drugs donated to the program and dispensed must be in their original sealed and tamper-evident
packaging ORC 3715.87 (B) (1). The packaging must be unopened, except that drugs packaged
in single unit doses may be accepted and dispensed when the outside packaging is opened if the
single unit dose packaging is undisturbed. ORC 3715.87 (B) (2). A drug will not be accepted or
dispensed if there is reason to believe it is adulterated. ORC 3715.87 (B) (3). Perhaps the most
common way for a drug to be considered adulterated is when the drugs strength differs from, or
its quality or purity falls below, the standard set forth in accepted references, such as United
States pharmacopoeia and national formulary. ORC 3715.63 (A) (5).

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Oral cancer drugs are treated differently. ORC 3715.87 (C). Those that do not require
refrigeration, freezing, or storage at a special temperature may be accepted and dispensed even if
not in original sealed and tamper-evident unit dose packaging. Oral cancer drugs must pass a
basic visual inspection that the drugs appear to be unadulterated, safe, and suitable for
dispensing. ORC 3715.873 (D). Controlled substances are not considered oral cancer drugs
for these purposes.

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The criteria from the legislature for donating prescription drugs to the drug repository program is
quite broad. Any person can donate. ORC 3715.871 (A). Likewise, a drug manufacturer or
health care facility (such as a hospital or nursing home) may also donate. ORC 1337.11 (I) (1)
and ORC 1337.11 (I) (3). The drugs must be donated at an approved pharmacy, hospital, or
nonprofit clinic that volunteers to participate in the drug repository program. ORC 3715.871
(A). Donated drugs may not be resold, though a handling fee may be charged. ORC 3715.871
(B).

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The Board further clarified that a person electing to donate must not have taken custody of the
drug prior to the donation. OAC 4729-35-03 (B). The person may direct the donation through a
terminal distributor of dangerous drugs, such as a participating community pharmacy. This
requirement ensures proper storage conditions and handling that may not be provided if the
person takes the drugs home. Also, persons in nursing homes, may elect to sign and date a donor
form prior to donating a drug. OAC 4729-35-03 (C) and OAC 4729-35-06. The donor form
must state from this day forward I wish to donate all my remaining unused drugs that are
eligible, pursuant to rule 4729-35-04 of the Administrative Code, to the drug repository
program. The Boards regulation also permits donation in cases where the patient may not be
competent to decide whether to donate, by allowing an individual responsible for the care and
well-being of a patient to make the decision to donate. OAC 4729-35-03 (D). This includes a
person designated by durable power of attorney or a patients guardian. OAC 4729-35-03 (D).

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What can be donated? See. OAC 4729-35-04. All prescription drugs, except controlled
substances and drug samples, may be donated - provided they meet all of the following
requirements:

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The drugs are in their original sealed and tamper-evident unit dose packaging. OAC
4729-35-04 (A). Pharmacy identifiers, such as labels, must be removed.
The drugs have been in the possession of a licensed healthcare professional only not a
patient. OAC 4729-35-04 (B).
The drugs have been stored according to Federal Food and Drug Administration storage
requirements. OAC 4729-35-04 (C).
The drugs must have an expiration date of six months or greater. OAC 4729-35-04 (D).
The packaging must list the lot number and expiration date of the drug. OAC 4729-35-04
(E).
The drugs must not have any signs of tampering or adulteration. OAC 4729-35-04 (F).
The drug packaging must not have any signs of tampering. OAC 4729-35-04 (G).
All patient information must be removed from the drug packaging. OAC 4729-35-04 (H).

A donor form must be completed prior to any donation, and include at least these details. OAC
4729-35-06.

A statement that the donor is the owner of the drug and intends to voluntarily donate the
drug to the drug repository program. OAC 4729-35-06 (A)
Either the name of the person that was originally dispensed the drugs, or the name of the
terminal distributor of dangerous drugs or wholesale distributor of dangerous drugs that
owns the drugs. OAC 4729-35-06 (A) (1).
The signature of the donor (such as the person designated by durable power of attorney, a
guardian, an individual responsible for the care and well-being of a patient, or the
signature of the responsible person or his/her designee from a terminal distributor of
dangerous drugs or a wholesale distributor of dangerous drugs.) OAC 4729-35-06 (A)
(2).
The date the form was signed. OAC 4729-35-06 (A) (3).
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Additional donor information must be recorded, and may be documented on the original signed
donor form or on an alternate record - which must include the name of the donor and:

The brand name of the drug donated, or the generic name and either the name of the
manufacturer or the national drug code number (NDC#). OAC 4729-35-06 (B) (1).
The strength of the drug donated. OAC 4729-35-06 (B) (2).
The quantity of the drug donated. OAC 4729-35-06 (B) (3).
The date the drug was donated. OAC 4729-35-06 (B) (4).

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Eligible patients, the programs recipients, are required to sign a recipient form stating they
understand the immunity provisions of the drug repository program. OAC 4729-35-07. A
significant degree of legal immunity is provided to those involved in the drug repository
program. ORC 3715.872 (B) (1). The immunity also extends to entities that dispenses drugs
under the program. ORC 3715.872 (B) (2). Health care professionals also enjoy this immunity,
as do the Board of Pharmacy and the director of health. ORC 3715.872 (B) (3) and ORC
3715.872 (B) (4). Only willful and wanton misconduct are actionable as civil matters. Drug
manufacturers that donate are similarly immune. ORC 3715.872 (D).

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The Board has established record keeping requirements for the drug repository program. OAC
4729-35-08. Donor forms must be maintained for a minimum of three years by a terminal
distributor of dangerous drugs, a wholesale distributor of dangerous drugs, or an institutional
facility. OAC 4729-35-08 (A). Recipient forms (signed by the patient) must be maintained for a
minimum of three years by a pharmacy, hospital, or nonprofit clinic. OAC 4729-35-08 (B).

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An invoice must be created by the donor, which includes a terminal distributor of dangerous
drugs, a wholesale distributor of dangerous drugs, or an institutional facility where the donor
resides. OAC 4729-35-08 (C). The invoice must include at least the following information:

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The name and address of the donor location. OAC 4729-35-08 (C) (1).
The brand name of the drug donated, or the generic name and list either the name of the
manufacturer or the national drug code number (NDC#). OAC 4729-35-08 (C) (2).
The strength of the drug. OAC 4729-35-08 (C) (3).
The quantity of the drug. OAC 4729-35-08 (C) (4).
The date the drug was sent to a pharmacy, hospital, or nonprofit clinic. OAC 4729-35-08
(C) (5).
The name and address of the recipient pharmacy, hospital, or nonprofit clinic. OAC
4729-35-08 (C) (6).

Prescribing and dispensing from the drug repository program inventory must be documented as
well. OAC 4729-35-08 (D). A prescriber must document the distribution of a donated
repository program drug to the patient. Each prescriber and terminal distributor of dangerous
drugs must keep a record of all dangerous drugs received, administered, dispensed, distributed,
sold, destroyed, or used. OAC 4729-9-22. This is standard record keeping for all prescription
drug transactions. Prescribing, administering, dispensing, and destroying of dangerous drugs
must be documented with the positive identification of the responsible individual. OAC 4729-5Page 7 of 12

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01 (N). These records may be kept electronically if the method is approved by the Board and the
records are backed-up each business day.

Records of receipt shall contain a description of all dangerous drugs received, the kind
and quantity of dangerous drugs received, the name and address of the persons from
whom received, and the date of receipt. OAC 4729-9-22 (A).
Records of administering, dispensing, or using dangerous drugs must contain a
description of the kind and quantity of the dangerous drugs administered, dispensed, sold,
or used, the date, the name and address of the patient. OAC 4729-9-22 (B).
Records of dangerous drug destructions, other than controlled substances, must contain
the name, strength, dosage form, and quantity of the dangerous drug destroyed, the date
destroyed, the method of destruction, the positive identification of the prescriber or
responsible person that performed the destruction, and if used the positive identification
of the person that witnessed the destruction. OAC 4729-9-22 (C).
All records must be kept for three years at the place where the dangerous drugs are
located and upon request provided to a Board officer, agent, and/or inspector within three
working days, excluding weekends and holidays. OAC 4729-9-22 (E).

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The pharmacy must document dispensing of a donated repository program drug in the same way
dispensing is documented in any other out-patient setting. OAC 4729-5-27. Both the prescriber
records and pharmacy records must indicate that the drug distributed to the patient was from the
drug repository program. OAC 4729-35-08 (D). Where recipient forms are used with each
dispensing, this information may be documented on the recipient form. OAC 4729-35-08 (D).

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A handling fee may be charged to the patient. OAC 4729-35-09. The limit for the fee is twenty
dollars ($20.00) to cover restocking and dispensing costs. A running tally of handling fees
collected should be maintained. The total of handling fees collected in any given year may not
exceed the program's total restocking and dispensing costs for that given year. Thus, where
handling fees are charged the pharmacy must also ascertain the total restocking and dispensing
costs for any given year. By the very nature of the program, the total restocking and dispensing
costs are not likely to be exceeded by handling fees collected from the patients for most clinics.

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Drug Donation vs Drug Takeback

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Care needs to be taken not to confuse the drug depository program, discussed in this lesson, and
the drug takeback program not discussed in this lesson. The pharmacist can help patients
understand the differences.

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A complete discussion of disposing of prescription drugs and controlled substances is beyond the
scope of this one-hour lesson. The following sections of the Ohio Administrative Code are
directed to the subject of drug takeback (also known as prescription drug collection):

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4729-8-01 Definitions
4729-8-02 Authorized collectors
4729-8-03 Law enforcement agencies
4729-8-04 Procedure for destruction of collected drugs
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Well-meaning patients or caregivers may show up at the pharmacy and want to donate drugs.
They should be directed to local law enforcement authorities or the DEA for details about any
upcoming takeback dates or drug drop box locations. To locate a prescription drug drop box
near you: http://rxdrugdropbox.org/map-search/.

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Patients may not understand the importance of proper handling and storage of medications, and
thus view donating medications as a sort of recycling program. To learn more about
pharmaceutical waste management, please visit:
http://www.deadiversion.usdoj.gov/drug_disposal/takeback/index.html.

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Additional resources are available for those wanting to learn more. The DEA published a rule on
September 9, 2014 directed to the destruction of controlled substances. See 79 FR 53519.
https://federalregister.gov/a/2014-20926. This rule governs the secure disposal of controlled
substances by registrants and ultimate users. The regulations implement the Secure and
Responsible Drug Disposal Act of 2010. Pub.L. 111-273.

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Conclusion

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The young and the indigent are recognized by lawmakers as needing additional care. Consult
your copy of Drug Laws of Ohio or other source for additional clarification. For opioids, most
of the new record keep requirements fall to our physician colleagues. The pharmacist is
obligated, as always, to use professional judgment and ensure medication provided is for a
legitimate medical purpose.

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The drug repository program is an important means of providing support for lower income
individuals unable to pay for medication. Provided the original intended patient does not take
possession of the medication, and the medication will not expire for at least six months, donation
is an option to consider.

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Questions choose the one most correct answer. A passing score is seventy percent.
1.
The new law concerning opioids for minors applies to which of the following?
a. Oxycodone
b. Codeine
c. Tramadol
d. all of the above
2.
The prescriber is exempted from discussing the potential for opioid abuse if the prescriber
determines doing so would be a detriment for the minors health or safety.
a. True
b. false
3.
Which of the following must be discussed when prescribing opioids to a minor during an
outpatient physician consultation?
a. risk of overdose
b. risk of addiction
c. danger of use of opiates with alcohol
d. all of the above
4.
Before prescribing opioids, the prescriber must assess whether the minor has suffered
from all but:
a. mental health disorder
b. substance abuse disorder
c. prior outpatient surgery
d. depression
5.
All but which of the following can donate to the drug repository program:
a. A patient whom has taken medication home from the pharmacy
b. Pharmaceutical manufacturer
c. Hospital
d. Chain pharmacy
6.
The recipients of the drug repository program must:
a. Have no reasonable financial means to pay
b. Be a resident of the county where the clinic is located
c. Be able to pay a fixed percentage of the prescription cost
d. Have no prescription coverage
7.
Which of the following may not be donated to the drug repository program:
a. alprazolam
b. fluoxetine
c. insulin
d. amoxicillin powder for reconstitution
8.
The pharmacist must receive a copy of the Start Talking! form before filling opioid
prescriptions for minors.
a. True
b. False

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9.

10.

Describe the relationship between dispensing handling fee and restocking and dispensing
costs in a drug repository program dispensing location:
a. The total of handling fees collected in any given year may exceed the program's total
restocking and dispensing costs for that given year.
b. The total of handling fees collected in any given year may not exceed the program's
total restocking and dispensing costs for that given year.
c. The total of handling fees collected for each patient may not exceed the patients
total restocking and dispensing costs in any given year.
d. None of the above.
When is the prescriber limited to prescribing a seventy-two (72) hour supply of opioids?
a. When a minor is treated in the absence of a parent or guardian
b. When a minor is treated in an outpatient setting, such as a physicians office
c. When another adult authorized by the minor's parent or guardian gives the required
consent
d. When a minor has a history of substance abuse

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Lesson number 036-368-15-009-H03 Answer Sheet: Expires November 30, 2017

Approved for one contact hour of Ohio Jurisprudence by the Ohio State Board of Pharmacy
Opioids to Minors and Drug Donation Programs
Answer Sheet circle the one correct best answer. Credit will be granted with seven correct.
Question Answer
Question
Answer
1
A B C D
6
A
B
C D
2
True
False
7
A
B
C D
True
False
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A B C D
8
A
B
C D
4
9
A B C D
5

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8
9
10
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B C D

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Please return by mail with check for $20 payable to James Lindon at:
James Lindon, Ph.D.
35104 Saddle Creek, Cleveland (Avon), Ohio 44011-4907
Phone 440-333-0011
You may also send payment via PayPal to JLindon at LindonLaw dot com

Submit answers online: http://www.lindonlaw.com/pharmacy-cpe/

Please fax or e-mail, [specify one, please] my continuing education certificate to:

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Pharmacist Name ____________________________

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Street Address ________________________________________________________

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City ______________

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E-Mail ___________________________________ Phone _____________________

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Ohio Pharmacist License Number _____________________

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NABP ID Number _____________________

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Copyright 2015 James Lindon, Lindon & Lindon LLC

Any views expressed are not necessarily those of the author or the law firm of Lindon & Lindon.
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