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Opioids to Minors and Drug Donation Programs1
Objectives2
By completing the lesson, the pharmacist will be able to:3
• Discuss Ohio’s new laws concerning use of opioids in minors4
• Describe the documents and record keeping for opioid prescriptions5
• Discuss Ohio’s donated drug repository program6
• Describe record keeping for drug repository program7
8
Introduction9
As pharmacists, we are aware that prescriptions for children receiving opioid analgesics require10
special attention. Ohio recently enacted new laws concerning use of opioid analgesics. While11
most of the burdens fall on the prescriber, pharmacists need to be aware of these changes to12
address questions about the law and understand the requirements. Ohio law also provides for13
donation of prescription drugs to treat economically disadvantaged persons. While these14
medications are in some sense “free” they come with record keeping requirements to assure15
medication integrity. This lesson will discuss the law in these subjects.16
Prescribing of Opioids to Minors17
The U.S. Food and Drug Administration approved OxyContin for children as young as eleven18
(11) years old on August 13, 2015. http://www.fda.gov/drugs/newsevents/ucm456973.htm. The19
use of OxyContin among children is not something new. However the rules directed to20
prescribing of opioids to minors are relatively new revisions to Ohio law. ORC 3719.061. The21
law creates a duty on the prescriber to do certain things before issuing to a minor the first22
prescription in a single course of treatment with an opioid analgesic:23
• As part of the prescriber's examination of the minor, assess whether the minor has ever24
suffered, or is currently suffering, from mental health or substance abuse disorders and25
whether the minor has taken or is currently taking prescription drugs for treatment of26
those disorders; ORC 3719.061 (B) (1)27
• Discuss with the minor and the minor's parent, guardian, or another adult authorized to28
consent to the minor's medical treatment all of the following: ORC 3719.061 (B) (2)29
o The risks of addiction and overdose associated with opioid analgesics; ORC30
3719.061 (B) (2) (a)31
o The increased risk of addiction to controlled substances of individuals suffering32
from both mental and substance abuse disorders; ORC 3719.061 (B) (2) (b)33
o The dangers of taking opioid analgesics with benzodiazepines, alcohol, or other34
central nervous system depressants; ORC 3719.061 (B) (2) (c)35
o Any other information in the patient counseling information section of the36
labeling for the opioid analgesic required under 21 C.F.R. 201.57(c)(18). ORC37
3719.061 (B) (2) (d).38
Page 2 of 12
Note: 21 C.F.R. 201.57(c)(18) is directed to information necessary for1
patients to use a drug safely and effectively (e.g., precautions concerning2
driving or the concomitant use of other substances that may have harmful3
additive effects).4
• The prescriber must also obtain written consent for the prescription from the minor's5
parent, guardian, or, subject to division (E) of this section, another adult authorized to6
consent to the minor's medical treatment. ORC 3719.061 (B) (3).7
• The prescriber must also record this consent on a form, known as the "Start Talking!"8
consent form. ORC 3719.061 (B) (3). This form must be separate from any other9
document the prescriber uses to obtain informed consent for other treatment provided to10
the minor. The form must contain all of the following:11
o The name and quantity of the opioid analgesic being prescribed and the amount of12
the initial dose; ORC 3719.061 (B) (3) (a)13
o A statement indicating that a controlled substance is a drug or other substance that14
the United States drug enforcement administration has identified as having a15
potential for abuse; ORC 3719.061 (B) (3) (b)16
o A statement certifying that the prescriber discussed with the minor and the17
minor's parent, guardian, or another adult authorized to consent to the minor's18
medical treatment the matters described in ORC 3719.061 (B) (2); ORC 3719.06119
(B) (3) (c)20
o The number of refills, if any, authorized by the prescription; ORC 3719.061 (B)21
(3) (d)22
o The signature of the minor's parent, guardian, or another adult authorized to23
consent to the minor's medical treatment and the date of signing. ORC 3719.06124
(B) (3) (e)25
• Exemptions. The prescriber does not need to have the “discussion” or obtain the “form”26
in the following scenarios:27
o The treatment is associated with or incident to a medical emergency. ORC28
3719.061 (C) (1) (a)29
o The treatment is associated with or incident to surgery, regardless of whether the30
surgery is performed on an inpatient or outpatient basis. ORC 3719.061 (C) (1)31
(b)32
o In the prescriber's professional judgment, fulfilling the requirements of division33
(B) of this section with respect to the minor's treatment would be a detriment to34
the minor's health or safety. ORC 3719.061 (C) (1) (c)35
o The treatment is rendered in a hospital, emergency facility, ambulatory surgical36
facility, nursing home, pediatric respite care program, residential care facility,37
freestanding rehabilitation facility, or similar institutional facility. ORC 3719.06138
(C) (1) (d)39
Note: The discussion and form ARE NEEDED when the minor is treated40
in a prescriber's office, even if located on the premises of, or adjacent to, a41
hospital, emergency facility, ambulatory surgical facility, nursing home,42
Page 3 of 12
pediatric respite care program, residential care facility, freestanding1
rehabilitation facility, or similar institutional facility. ORC 3719.061 (D)2
• Limits. No more than a seventy-two (72) hour supply of a controlled substance3
containing an opioid may be prescribed when another adult authorized by the minor's4
parent or guardian gives the required consent. ORC 3719.061 (E). For example, if the5
parents give written authorization to consent to medical treatment to a child’s Aunt, the6
prescriber can prescribe no more than a seventy-two (72) hour supply of hydrocodone for7
the child when the Aunt takes the child for treatment. The Aunt has less authority to8
consent than the parent or custodial guardian.9
• The “Start Talking!” form must be maintained in the minor’s medical record. ORC10
3719.061 (F).11
Defined as an opioid analgesic as of March 2015. ORC 3719.0112
Generic Name Brand Name Schedule
Buprenorphine BUTRANS, BUPRENEX Schedule III
Butorphanol BUTORPHANOL NS Schedule IV
Codeine (acetaminophen
and other combination
products)
TYLENOL W. CODEINE #3, TYLENOL W.
CODEINE #4
Schedule III
Dihydrocodeine/ASA/caffei
ne
SYNALGOS-DC Schedule III
Fentanyl DURAGESIC, ACTIQ, ABSTRAL,
LAZANDA, FENTORA, SUBSYS,
SUBLIMAZE, ONSOLIS, IONSYS
Schedule II
Hydrocodone ZOHYDRO ER Schedule II
Hydrocodone
(acetaminophen
combination products)
XODOL, MAXIDONE, ZYDONE, LORCET,
HYCET, ZAMICET, CO-GESIC, ZOLVIT,
STAGESIC, LIQUICET, LORTAB, VICODIN,
NORCO
Schedule II
(October 6, 2014)
Hydrocodone (ibuprofen
combination products)
IBUDONE, REPREXAIN, VICOPROFEN Schedule II
Hydromorphone DILAUDID, EXALGO Schedule II
Meperidine DEMEROL Schedule II
Methadone DOLOPHINE, METHADOSE Schedule II
Morphine Sulfate MS CONTIN, AVINZA, DURAMORPH,
KADIAN, DEPODUR, ASTRAMORPH,
IMFUMORPH
Schedule II
Oxycodone OXECTA, ROXICODONE, OXYCONTIN Schedule II
Oxycodone (acetaminophen,
aspirin and other
combination products)
PERCODAN, PERCOCET, ROXICET,
ENDOCET, XOLOX, TYLOX, PRIMLEV,
MAGNACET, XARTEMIS XR
Schedule II
Oxymorphone OPANA, NUMORPHAN Schedule II
Tapentadol NUCYNTA Schedule II
Tramadol ULTRAM, ULTRACET, RYZOLT, CONZIP,
RYBIX
Schedule IV
(August 18, 2014)
13
Page 4 of 12
Role of the Pharmacist1
Of course, the pharmacist should always use professional judgment before dispensing any2
medication, particularly controlled substances. Some common sense points for the pharmacist to3
keep in mind include:4
• Pharmacists should be prepared to assure parents of young patients that presenting a copy5
of the “Start Talking!” form to the pharmacist is not legally required to fill a legitimate6
prescription.7
• Pharmacists should be prepared to communicate that the form is an important part of the8
education process for proper use of opioids.9
• Pediatric patients with legitimate prescriptions should be treated with the same10
compassion as any other patient.11
• Untreated pain is a problem just as much as drug abuse is a problem.12
• Under-treated pain is a problem just as much as drug abuse is a problem.13
• Exaggerated fears of addiction should not interfere with the proper evaluation and14
treatment of pain.15
• If the pharmacist believes that the patient and the caregiver were somehow not included16
in a discussion with the prescriber about proper use of opioids, the pharmacist should17
consider an appropriate discussion of:18
o The risks of addiction and overdose associated with opioid analgesics19
o The increased risk of addiction to controlled substances of individuals suffering20
from either mental and substance abuse disorders21
o The dangers of taking opioid analgesics with benzodiazepines, alcohol, or other22
central nervous system depressants23
o Any other information necessary for patients to use the medication safely and24
effectively (e.g., precautions concerning driving or drug interactions, and the like)25
Though the new record keeping requirements create tasks to be performed by prescribers, the26
pharmacist should note red flags which could indicate diversion:27
• Patients or caregivers travelling extremely long distances to have a prescription filled.28
Most prescriptions will be filled nearby a prescriber’s office, the patient’s or caregiver’s29
residence, or a caregiver’s place of work.30
• Very high doses of opioids being prescribed for young patients. Though pediatric31
patients develop tolerance like any patient, comparatively smaller body weights of32
pediatric patients are also to be considered.33
• Opiates being prescribed for very young patients for very long periods of time. There34
are, of course, some children afflicted with conditions traditionally associated with adults.35
The pain and suffering of children should be treated appropriately and not ignored.36
• A disproportionate number of prescriptions coming from one prescriber. Unless the37
prescriber has a very specialized practice, the quantity of opioid prescription from any38
given prescriber should be fairly similar to colleagues in that type of practice.39
Page 5 of 12
• Prescribers issuing prescriptions that may be outside of their scope of practice. The1
pharmacist may expect that a specialist, such as a pediatric oncologist, might prescribe2
more opioids for children than a cardiologist.3
Drug Repository Program for Donated Prescription Drugs4
Community pharmacists are well aware of the economic pressure in daily practice. It would be5
rare indeed for the pharmacist not to have some sort of discussion with a patient about6
prescription drug costs every day. While they are not the solution for everybody, “free clinics”7
have a role to play in assisting patients. Information about free clinics and their locations may be8
found online at:9
• http://ohiofreeclinics.org/10
• http://ohiofreeclinics.org/who-we-are/locations/find-a-clinic.html11
The Ohio State Legislature has established a drug repository program for donated prescription12
drugs. ORC 3715.87. The purpose of the program is to provide medication to be dispensed to13
individuals who are residents of Ohio and meet eligibility standards established in rules adopted14
by the Board. Basically, the recipient must have “no reasonable financial means to pay for the15
drug prescribed” and be a “patient of a nonprofit clinic.” OAC 4729-35-05 (B) (1) and 4729-35-16
05 (B) (2).17
Drugs donated to the program and dispensed must be in their original sealed and tamper-evident18
packaging ORC 3715.87 (B) (1). The packaging must be unopened, except that drugs packaged19
in single unit doses may be accepted and dispensed when the outside packaging is opened if the20
single unit dose packaging is undisturbed. ORC 3715.87 (B) (2). A drug will not be accepted or21
dispensed if there is reason to believe it is adulterated. ORC 3715.87 (B) (3). Perhaps the most22
common way for a drug to be considered adulterated is when the drug’s strength differs from, or23
its quality or purity falls below, the standard set forth in accepted references, such as United24
States pharmacopoeia and national formulary. ORC 3715.63 (A) (5).25
Oral cancer drugs are treated differently. ORC 3715.87 (C). Those that do not require26
refrigeration, freezing, or storage at a special temperature may be accepted and dispensed even if27
not in original sealed and tamper-evident unit dose packaging. Oral cancer drugs must pass a28
“basic visual inspection” that the drugs appear to be unadulterated, safe, and suitable for29
dispensing. ORC 3715.873 (D). Controlled substances are not considered “oral cancer drugs”30
for these purposes.31
The criteria from the legislature for donating prescription drugs to the drug repository program is32
quite broad. Any “person” can donate. ORC 3715.871 (A). Likewise, a drug manufacturer or33
health care facility (such as a hospital or nursing home) may also donate. ORC 1337.11 (I) (1)34
and ORC 1337.11 (I) (3). The drugs must be donated at an approved pharmacy, hospital, or35
nonprofit clinic that volunteers to participate in the drug repository program. ORC 3715.87136
(A). Donated drugs may not be resold, though a handling fee may be charged. ORC 3715.87137
(B).38
Page 6 of 12
The Board further clarified that a person electing to donate must not have taken custody of the1
drug prior to the donation. OAC 4729-35-03 (B). The person may direct the donation through a2
terminal distributor of dangerous drugs, such as a participating community pharmacy. This3
requirement ensures proper storage conditions and handling – that may not be provided if the4
person takes the drugs home. Also, persons in nursing homes, may elect to sign and date a donor5
form prior to donating a drug. OAC 4729-35-03 (C) and OAC 4729-35-06. The donor form6
must state “from this day forward I wish to donate all my remaining unused drugs that are7
eligible, pursuant to rule 4729-35-04 of the Administrative Code, to the drug repository8
program.” The Board’s regulation also permits donation in cases where the patient may not be9
competent to decide whether to donate, by allowing an individual responsible for the care and10
well-being of a patient to make the decision to donate. OAC 4729-35-03 (D). This includes a11
person designated by durable power of attorney or a patient’s guardian. OAC 4729-35-03 (D).12
What can be donated? See. OAC 4729-35-04. All prescription drugs, except controlled13
substances and drug samples, may be donated - provided they meet all of the following14
requirements:15
• The drugs are in their original sealed and tamper-evident unit dose packaging. OAC16
4729-35-04 (A). Pharmacy identifiers, such as labels, must be removed.17
• The drugs have been in the possession of a licensed healthcare professional only – not a18
patient. OAC 4729-35-04 (B).19
• The drugs have been stored according to Federal Food and Drug Administration storage20
requirements. OAC 4729-35-04 (C).21
• The drugs must have an expiration date of six months or greater. OAC 4729-35-04 (D).22
• The packaging must list the lot number and expiration date of the drug. OAC 4729-35-0423
(E).24
• The drugs must not have any signs of tampering or adulteration. OAC 4729-35-04 (F).25
• The drug packaging must not have any signs of tampering. OAC 4729-35-04 (G).26
• All patient information must be removed from the drug packaging. OAC 4729-35-04 (H).27
A donor form must be completed prior to any donation, and include at least these details. OAC28
4729-35-06.29
• A statement that the donor is the owner of the drug and intends to voluntarily donate the30
drug to the drug repository program. OAC 4729-35-06 (A)31
• Either the name of the person that was originally dispensed the drugs, or the name of the32
terminal distributor of dangerous drugs or wholesale distributor of dangerous drugs that33
owns the drugs. OAC 4729-35-06 (A) (1).34
• The signature of the donor (such as the person designated by durable power of attorney, a35
guardian, an individual responsible for the care and well-being of a patient, or the36
signature of the responsible person or his/her designee from a terminal distributor of37
dangerous drugs or a wholesale distributor of dangerous drugs.) OAC 4729-35-06 (A)38
(2).39
• The date the form was signed. OAC 4729-35-06 (A) (3).40
Page 7 of 12
Additional donor information must be recorded, and may be documented on the original signed1
donor form or on an alternate record - which must include the name of the donor and:2
• The brand name of the drug donated, or the generic name and either the name of the3
manufacturer or the national drug code number (NDC#). OAC 4729-35-06 (B) (1).4
• The strength of the drug donated. OAC 4729-35-06 (B) (2).5
• The quantity of the drug donated. OAC 4729-35-06 (B) (3).6
• The date the drug was donated. OAC 4729-35-06 (B) (4).7
Eligible patients, the program’s recipients, are required to sign a recipient form stating they8
understand the immunity provisions of the drug repository program. OAC 4729-35-07. A9
significant degree of legal immunity is provided to those involved in the drug repository10
program. ORC 3715.872 (B) (1). The immunity also extends to entities that dispenses drugs11
under the program. ORC 3715.872 (B) (2). Health care professionals also enjoy this immunity,12
as do the Board of Pharmacy and the director of health. ORC 3715.872 (B) (3) and ORC13
3715.872 (B) (4). Only willful and wanton misconduct are actionable as civil matters. Drug14
manufacturers that donate are similarly immune. ORC 3715.872 (D).15
The Board has established record keeping requirements for the drug repository program. OAC16
4729-35-08. Donor forms must be maintained for a minimum of three years by a terminal17
distributor of dangerous drugs, a wholesale distributor of dangerous drugs, or an institutional18
facility. OAC 4729-35-08 (A). Recipient forms (signed by the patient) must be maintained for a19
minimum of three years by a pharmacy, hospital, or nonprofit clinic. OAC 4729-35-08 (B).20
An invoice must be created by the donor, which includes a terminal distributor of dangerous21
drugs, a wholesale distributor of dangerous drugs, or an institutional facility where the donor22
resides. OAC 4729-35-08 (C). The invoice must include at least the following information:23
• The name and address of the donor location. OAC 4729-35-08 (C) (1).24
• The brand name of the drug donated, or the generic name and list either the name of the25
manufacturer or the national drug code number (NDC#). OAC 4729-35-08 (C) (2).26
• The strength of the drug. OAC 4729-35-08 (C) (3).27
• The quantity of the drug. OAC 4729-35-08 (C) (4).28
• The date the drug was sent to a pharmacy, hospital, or nonprofit clinic. OAC 4729-35-0829
(C) (5).30
• The name and address of the recipient pharmacy, hospital, or nonprofit clinic. OAC31
4729-35-08 (C) (6).32
Prescribing and dispensing from the drug repository program inventory must be documented as33
well. OAC 4729-35-08 (D). A prescriber must document the distribution of a donated34
repository program drug to the patient. Each prescriber and terminal distributor of dangerous35
drugs must keep a record of all dangerous drugs received, administered, dispensed, distributed,36
sold, destroyed, or used. OAC 4729-9-22. This is standard record keeping for all prescription37
drug transactions. Prescribing, administering, dispensing, and destroying of dangerous drugs38
must be documented with the positive identification of the responsible individual. OAC 4729-5-39
Page 8 of 12
01 (N). These records may be kept electronically if the method is approved by the Board and the1
records are backed-up each business day.2
• Records of receipt shall contain a description of all dangerous drugs received, the kind3
and quantity of dangerous drugs received, the name and address of the persons from4
whom received, and the date of receipt. OAC 4729-9-22 (A).5
• Records of administering, dispensing, or using dangerous drugs must contain a6
description of the kind and quantity of the dangerous drugs administered, dispensed, sold,7
or used, the date, the name and address of the patient. OAC 4729-9-22 (B).8
• Records of dangerous drug destructions, other than controlled substances, must contain9
the name, strength, dosage form, and quantity of the dangerous drug destroyed, the date10
destroyed, the method of destruction, the positive identification of the prescriber or11
responsible person that performed the destruction, and if used the positive identification12
of the person that witnessed the destruction. OAC 4729-9-22 (C).13
• All records must be kept for three years at the place where the dangerous drugs are14
located and upon request provided to a Board officer, agent, and/or inspector within three15
working days, excluding weekends and holidays. OAC 4729-9-22 (E).16
The pharmacy must document dispensing of a donated repository program drug in the same way17
dispensing is documented in any other out-patient setting. OAC 4729-5-27. Both the prescriber18
records and pharmacy records must indicate that the drug distributed to the patient was from the19
drug repository program. OAC 4729-35-08 (D). Where recipient forms are used with each20
dispensing, this information may be documented on the recipient form. OAC 4729-35-08 (D).21
A handling fee may be charged to the patient. OAC 4729-35-09. The limit for the fee is twenty22
dollars ($20.00) to cover restocking and dispensing costs. A running tally of handling fees23
collected should be maintained. The total of handling fees collected in any given year may not24
exceed the program's total restocking and dispensing costs for that given year. Thus, where25
handling fees are charged the pharmacy must also ascertain the total restocking and dispensing26
costs for any given year. By the very nature of the program, the total restocking and dispensing27
costs are not likely to be exceeded by handling fees collected from the patients for most clinics.28
Drug Donation vs Drug Takeback29
Care needs to be taken not to confuse the drug depository program, discussed in this lesson, and30
the drug takeback program – not discussed in this lesson. The pharmacist can help patients31
understand the differences.32
A complete discussion of disposing of prescription drugs and controlled substances is beyond the33
scope of this one-hour lesson. The following sections of the Ohio Administrative Code are34
directed to the subject of drug takeback (also known as prescription drug collection):35
• 4729-8-01 Definitions36
• 4729-8-02 Authorized collectors37
• 4729-8-03 Law enforcement agencies38
• 4729-8-04 Procedure for destruction of collected drugs39
Page 9 of 12
Well-meaning patients or caregivers may show up at the pharmacy and want to donate drugs.1
They should be directed to local law enforcement authorities or the DEA for details about any2
upcoming takeback dates or drug drop box locations. To locate a prescription drug drop box3
near you: http://rxdrugdropbox.org/map-search/.4
Patients may not understand the importance of proper handling and storage of medications, and5
thus view donating medications as a sort of recycling program. To learn more about6
pharmaceutical waste management, please visit:7
http://www.deadiversion.usdoj.gov/drug_disposal/takeback/index.html.8
Additional resources are available for those wanting to learn more. The DEA published a rule on9
September 9, 2014 directed to the destruction of controlled substances. See 79 FR 53519.10
https://federalregister.gov/a/2014-20926. This rule governs the secure disposal of controlled11
substances by registrants and ultimate users. The regulations implement the Secure and12
Responsible Drug Disposal Act of 2010. Pub.L. 111-273.13
Conclusion14
The young and the indigent are recognized by lawmakers as needing additional care. Consult15
your copy of Drug Laws of Ohio or other source for additional clarification. For opioids, most16
of the new record keep requirements fall to our physician colleagues. The pharmacist is17
obligated, as always, to use professional judgment and ensure medication provided is for a18
legitimate medical purpose.19
The drug repository program is an important means of providing support for lower income20
individuals unable to pay for medication. Provided the original intended patient does not take21
possession of the medication, and the medication will not expire for at least six months, donation22
is an option to consider.23
24
Page 10 of 12
Questions – choose the one most correct answer. A passing score is seventy percent.1
1. The new law concerning opioids for minors applies to which of the following?2
a. Oxycodone3
b. Codeine4
c. Tramadol5
d. all of the above6
2. The prescriber is exempted from discussing the potential for opioid abuse if the prescriber7
determines doing so would be a detriment for the minor’s health or safety.8
a. True9
b. false10
3. Which of the following must be discussed when prescribing opioids to a minor during an11
outpatient physician consultation?12
a. risk of overdose13
b. risk of addiction14
c. danger of use of opiates with alcohol15
d. all of the above16
4. Before prescribing opioids, the prescriber must assess whether the minor has suffered17
from all but:18
a. mental health disorder19
b. substance abuse disorder20
c. prior outpatient surgery21
d. depression22
5. All but which of the following can donate to the drug repository program:23
a. A patient whom has taken medication home from the pharmacy24
b. Pharmaceutical manufacturer25
c. Hospital26
d. Chain pharmacy27
6. The recipients of the drug repository program must:28
a. Have no reasonable financial means to pay29
b. Be a resident of the county where the clinic is located30
c. Be able to pay a fixed percentage of the prescription cost31
d. Have no prescription coverage32
7. Which of the following may not be donated to the drug repository program:33
a. alprazolam34
b. fluoxetine35
c. insulin36
d. amoxicillin powder for reconstitution37
8. The pharmacist must receive a copy of the “Start Talking!” form before filling opioid38
prescriptions for minors.39
a. True40
b. False41
Page 11 of 12
9. Describe the relationship between dispensing handling fee and restocking and dispensing1
costs in a drug repository program dispensing location:2
a. The total of handling fees collected in any given year may exceed the program's total3
restocking and dispensing costs for that given year.4
b. The total of handling fees collected in any given year may not exceed the program's5
total restocking and dispensing costs for that given year.6
c. The total of handling fees collected for each patient may not exceed the patient’s7
total restocking and dispensing costs in any given year.8
d. None of the above.9
10. When is the prescriber limited to prescribing a seventy-two (72) hour supply of opioids?10
a. When a minor is treated in the absence of a parent or guardian11
b. When a minor is treated in an outpatient setting, such as a physician’s office12
c. When another adult authorized by the minor's parent or guardian gives the required13
consent14
d. When a minor has a history of substance abuse15
16
17
Page 12 of 12
Lesson number 036-368-15-009-H03 Answer Sheet: Expires November 30, 20171
Approved for one contact hour of Ohio Jurisprudence by the Ohio State Board of Pharmacy2
3
Opioids to Minors and Drug Donation Programs4
Answer Sheet – circle the one correct best answer. Credit will be granted with seven correct.5
Question Answer Question Answer
1 A B C D 6 A B C D
2 True False 7 A B C D
3 A B C D 8 True False
4 A B C D 9 A B C D
5 A B C D 10 A B C D
6
Please return by mail with check for $20 payable to James Lindon at:7
James Lindon, Ph.D.8
35104 Saddle Creek, Cleveland (Avon), Ohio 44011-49079
Phone 440-333-001110
You may also send payment via PayPal to JLindon at LindonLaw dot com11
Submit answers online: http://www.lindonlaw.com/pharmacy-cpe/12
13
Please fax or e-mail, [specify one, please] my continuing education certificate to:14
Pharmacist Name ____________________________15
Street Address ________________________________________________________16
City ______________ State _______ Zip _____________17
E-Mail ___________________________________ Phone _____________________18
Ohio Pharmacist License Number _____________________19
NABP ID Number _____________________20
21
Copyright 2015 James Lindon, Lindon & Lindon LLC22
Any views expressed are not necessarily those of the author or the law firm of Lindon & Lindon.23
Program Evaluation (please circle one response to each question):24
After completing this lesson I can achieve the lesson objectives: Yes No25
This program was an effective way for me to learn: Yes No26
I liked the program’s format: Yes No27
This program fostered my mental participation: Yes No28
This was a “user-friendly” way for me to learn: Yes No29
I could sense some commercialism in this program: Yes No30
If yes, please describe: ______________________________________________31
The faculty quality was: Great OK Needs to Improve32
The learning material quality was: Great OK Needs to Improve33
How long did it take to complete this program? _______________________34
What other topics would you like to see? ____________________________35
Comments welcome: ____________________________________________36
37

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Opioids to Minors and Drug Donation Programs - lesson

  • 1. Page 1 of 12 Opioids to Minors and Drug Donation Programs1 Objectives2 By completing the lesson, the pharmacist will be able to:3 • Discuss Ohio’s new laws concerning use of opioids in minors4 • Describe the documents and record keeping for opioid prescriptions5 • Discuss Ohio’s donated drug repository program6 • Describe record keeping for drug repository program7 8 Introduction9 As pharmacists, we are aware that prescriptions for children receiving opioid analgesics require10 special attention. Ohio recently enacted new laws concerning use of opioid analgesics. While11 most of the burdens fall on the prescriber, pharmacists need to be aware of these changes to12 address questions about the law and understand the requirements. Ohio law also provides for13 donation of prescription drugs to treat economically disadvantaged persons. While these14 medications are in some sense “free” they come with record keeping requirements to assure15 medication integrity. This lesson will discuss the law in these subjects.16 Prescribing of Opioids to Minors17 The U.S. Food and Drug Administration approved OxyContin for children as young as eleven18 (11) years old on August 13, 2015. http://www.fda.gov/drugs/newsevents/ucm456973.htm. The19 use of OxyContin among children is not something new. However the rules directed to20 prescribing of opioids to minors are relatively new revisions to Ohio law. ORC 3719.061. The21 law creates a duty on the prescriber to do certain things before issuing to a minor the first22 prescription in a single course of treatment with an opioid analgesic:23 • As part of the prescriber's examination of the minor, assess whether the minor has ever24 suffered, or is currently suffering, from mental health or substance abuse disorders and25 whether the minor has taken or is currently taking prescription drugs for treatment of26 those disorders; ORC 3719.061 (B) (1)27 • Discuss with the minor and the minor's parent, guardian, or another adult authorized to28 consent to the minor's medical treatment all of the following: ORC 3719.061 (B) (2)29 o The risks of addiction and overdose associated with opioid analgesics; ORC30 3719.061 (B) (2) (a)31 o The increased risk of addiction to controlled substances of individuals suffering32 from both mental and substance abuse disorders; ORC 3719.061 (B) (2) (b)33 o The dangers of taking opioid analgesics with benzodiazepines, alcohol, or other34 central nervous system depressants; ORC 3719.061 (B) (2) (c)35 o Any other information in the patient counseling information section of the36 labeling for the opioid analgesic required under 21 C.F.R. 201.57(c)(18). ORC37 3719.061 (B) (2) (d).38
  • 2. Page 2 of 12 Note: 21 C.F.R. 201.57(c)(18) is directed to information necessary for1 patients to use a drug safely and effectively (e.g., precautions concerning2 driving or the concomitant use of other substances that may have harmful3 additive effects).4 • The prescriber must also obtain written consent for the prescription from the minor's5 parent, guardian, or, subject to division (E) of this section, another adult authorized to6 consent to the minor's medical treatment. ORC 3719.061 (B) (3).7 • The prescriber must also record this consent on a form, known as the "Start Talking!"8 consent form. ORC 3719.061 (B) (3). This form must be separate from any other9 document the prescriber uses to obtain informed consent for other treatment provided to10 the minor. The form must contain all of the following:11 o The name and quantity of the opioid analgesic being prescribed and the amount of12 the initial dose; ORC 3719.061 (B) (3) (a)13 o A statement indicating that a controlled substance is a drug or other substance that14 the United States drug enforcement administration has identified as having a15 potential for abuse; ORC 3719.061 (B) (3) (b)16 o A statement certifying that the prescriber discussed with the minor and the17 minor's parent, guardian, or another adult authorized to consent to the minor's18 medical treatment the matters described in ORC 3719.061 (B) (2); ORC 3719.06119 (B) (3) (c)20 o The number of refills, if any, authorized by the prescription; ORC 3719.061 (B)21 (3) (d)22 o The signature of the minor's parent, guardian, or another adult authorized to23 consent to the minor's medical treatment and the date of signing. ORC 3719.06124 (B) (3) (e)25 • Exemptions. The prescriber does not need to have the “discussion” or obtain the “form”26 in the following scenarios:27 o The treatment is associated with or incident to a medical emergency. ORC28 3719.061 (C) (1) (a)29 o The treatment is associated with or incident to surgery, regardless of whether the30 surgery is performed on an inpatient or outpatient basis. ORC 3719.061 (C) (1)31 (b)32 o In the prescriber's professional judgment, fulfilling the requirements of division33 (B) of this section with respect to the minor's treatment would be a detriment to34 the minor's health or safety. ORC 3719.061 (C) (1) (c)35 o The treatment is rendered in a hospital, emergency facility, ambulatory surgical36 facility, nursing home, pediatric respite care program, residential care facility,37 freestanding rehabilitation facility, or similar institutional facility. ORC 3719.06138 (C) (1) (d)39 Note: The discussion and form ARE NEEDED when the minor is treated40 in a prescriber's office, even if located on the premises of, or adjacent to, a41 hospital, emergency facility, ambulatory surgical facility, nursing home,42
  • 3. Page 3 of 12 pediatric respite care program, residential care facility, freestanding1 rehabilitation facility, or similar institutional facility. ORC 3719.061 (D)2 • Limits. No more than a seventy-two (72) hour supply of a controlled substance3 containing an opioid may be prescribed when another adult authorized by the minor's4 parent or guardian gives the required consent. ORC 3719.061 (E). For example, if the5 parents give written authorization to consent to medical treatment to a child’s Aunt, the6 prescriber can prescribe no more than a seventy-two (72) hour supply of hydrocodone for7 the child when the Aunt takes the child for treatment. The Aunt has less authority to8 consent than the parent or custodial guardian.9 • The “Start Talking!” form must be maintained in the minor’s medical record. ORC10 3719.061 (F).11 Defined as an opioid analgesic as of March 2015. ORC 3719.0112 Generic Name Brand Name Schedule Buprenorphine BUTRANS, BUPRENEX Schedule III Butorphanol BUTORPHANOL NS Schedule IV Codeine (acetaminophen and other combination products) TYLENOL W. CODEINE #3, TYLENOL W. CODEINE #4 Schedule III Dihydrocodeine/ASA/caffei ne SYNALGOS-DC Schedule III Fentanyl DURAGESIC, ACTIQ, ABSTRAL, LAZANDA, FENTORA, SUBSYS, SUBLIMAZE, ONSOLIS, IONSYS Schedule II Hydrocodone ZOHYDRO ER Schedule II Hydrocodone (acetaminophen combination products) XODOL, MAXIDONE, ZYDONE, LORCET, HYCET, ZAMICET, CO-GESIC, ZOLVIT, STAGESIC, LIQUICET, LORTAB, VICODIN, NORCO Schedule II (October 6, 2014) Hydrocodone (ibuprofen combination products) IBUDONE, REPREXAIN, VICOPROFEN Schedule II Hydromorphone DILAUDID, EXALGO Schedule II Meperidine DEMEROL Schedule II Methadone DOLOPHINE, METHADOSE Schedule II Morphine Sulfate MS CONTIN, AVINZA, DURAMORPH, KADIAN, DEPODUR, ASTRAMORPH, IMFUMORPH Schedule II Oxycodone OXECTA, ROXICODONE, OXYCONTIN Schedule II Oxycodone (acetaminophen, aspirin and other combination products) PERCODAN, PERCOCET, ROXICET, ENDOCET, XOLOX, TYLOX, PRIMLEV, MAGNACET, XARTEMIS XR Schedule II Oxymorphone OPANA, NUMORPHAN Schedule II Tapentadol NUCYNTA Schedule II Tramadol ULTRAM, ULTRACET, RYZOLT, CONZIP, RYBIX Schedule IV (August 18, 2014) 13
  • 4. Page 4 of 12 Role of the Pharmacist1 Of course, the pharmacist should always use professional judgment before dispensing any2 medication, particularly controlled substances. Some common sense points for the pharmacist to3 keep in mind include:4 • Pharmacists should be prepared to assure parents of young patients that presenting a copy5 of the “Start Talking!” form to the pharmacist is not legally required to fill a legitimate6 prescription.7 • Pharmacists should be prepared to communicate that the form is an important part of the8 education process for proper use of opioids.9 • Pediatric patients with legitimate prescriptions should be treated with the same10 compassion as any other patient.11 • Untreated pain is a problem just as much as drug abuse is a problem.12 • Under-treated pain is a problem just as much as drug abuse is a problem.13 • Exaggerated fears of addiction should not interfere with the proper evaluation and14 treatment of pain.15 • If the pharmacist believes that the patient and the caregiver were somehow not included16 in a discussion with the prescriber about proper use of opioids, the pharmacist should17 consider an appropriate discussion of:18 o The risks of addiction and overdose associated with opioid analgesics19 o The increased risk of addiction to controlled substances of individuals suffering20 from either mental and substance abuse disorders21 o The dangers of taking opioid analgesics with benzodiazepines, alcohol, or other22 central nervous system depressants23 o Any other information necessary for patients to use the medication safely and24 effectively (e.g., precautions concerning driving or drug interactions, and the like)25 Though the new record keeping requirements create tasks to be performed by prescribers, the26 pharmacist should note red flags which could indicate diversion:27 • Patients or caregivers travelling extremely long distances to have a prescription filled.28 Most prescriptions will be filled nearby a prescriber’s office, the patient’s or caregiver’s29 residence, or a caregiver’s place of work.30 • Very high doses of opioids being prescribed for young patients. Though pediatric31 patients develop tolerance like any patient, comparatively smaller body weights of32 pediatric patients are also to be considered.33 • Opiates being prescribed for very young patients for very long periods of time. There34 are, of course, some children afflicted with conditions traditionally associated with adults.35 The pain and suffering of children should be treated appropriately and not ignored.36 • A disproportionate number of prescriptions coming from one prescriber. Unless the37 prescriber has a very specialized practice, the quantity of opioid prescription from any38 given prescriber should be fairly similar to colleagues in that type of practice.39
  • 5. Page 5 of 12 • Prescribers issuing prescriptions that may be outside of their scope of practice. The1 pharmacist may expect that a specialist, such as a pediatric oncologist, might prescribe2 more opioids for children than a cardiologist.3 Drug Repository Program for Donated Prescription Drugs4 Community pharmacists are well aware of the economic pressure in daily practice. It would be5 rare indeed for the pharmacist not to have some sort of discussion with a patient about6 prescription drug costs every day. While they are not the solution for everybody, “free clinics”7 have a role to play in assisting patients. Information about free clinics and their locations may be8 found online at:9 • http://ohiofreeclinics.org/10 • http://ohiofreeclinics.org/who-we-are/locations/find-a-clinic.html11 The Ohio State Legislature has established a drug repository program for donated prescription12 drugs. ORC 3715.87. The purpose of the program is to provide medication to be dispensed to13 individuals who are residents of Ohio and meet eligibility standards established in rules adopted14 by the Board. Basically, the recipient must have “no reasonable financial means to pay for the15 drug prescribed” and be a “patient of a nonprofit clinic.” OAC 4729-35-05 (B) (1) and 4729-35-16 05 (B) (2).17 Drugs donated to the program and dispensed must be in their original sealed and tamper-evident18 packaging ORC 3715.87 (B) (1). The packaging must be unopened, except that drugs packaged19 in single unit doses may be accepted and dispensed when the outside packaging is opened if the20 single unit dose packaging is undisturbed. ORC 3715.87 (B) (2). A drug will not be accepted or21 dispensed if there is reason to believe it is adulterated. ORC 3715.87 (B) (3). Perhaps the most22 common way for a drug to be considered adulterated is when the drug’s strength differs from, or23 its quality or purity falls below, the standard set forth in accepted references, such as United24 States pharmacopoeia and national formulary. ORC 3715.63 (A) (5).25 Oral cancer drugs are treated differently. ORC 3715.87 (C). Those that do not require26 refrigeration, freezing, or storage at a special temperature may be accepted and dispensed even if27 not in original sealed and tamper-evident unit dose packaging. Oral cancer drugs must pass a28 “basic visual inspection” that the drugs appear to be unadulterated, safe, and suitable for29 dispensing. ORC 3715.873 (D). Controlled substances are not considered “oral cancer drugs”30 for these purposes.31 The criteria from the legislature for donating prescription drugs to the drug repository program is32 quite broad. Any “person” can donate. ORC 3715.871 (A). Likewise, a drug manufacturer or33 health care facility (such as a hospital or nursing home) may also donate. ORC 1337.11 (I) (1)34 and ORC 1337.11 (I) (3). The drugs must be donated at an approved pharmacy, hospital, or35 nonprofit clinic that volunteers to participate in the drug repository program. ORC 3715.87136 (A). Donated drugs may not be resold, though a handling fee may be charged. ORC 3715.87137 (B).38
  • 6. Page 6 of 12 The Board further clarified that a person electing to donate must not have taken custody of the1 drug prior to the donation. OAC 4729-35-03 (B). The person may direct the donation through a2 terminal distributor of dangerous drugs, such as a participating community pharmacy. This3 requirement ensures proper storage conditions and handling – that may not be provided if the4 person takes the drugs home. Also, persons in nursing homes, may elect to sign and date a donor5 form prior to donating a drug. OAC 4729-35-03 (C) and OAC 4729-35-06. The donor form6 must state “from this day forward I wish to donate all my remaining unused drugs that are7 eligible, pursuant to rule 4729-35-04 of the Administrative Code, to the drug repository8 program.” The Board’s regulation also permits donation in cases where the patient may not be9 competent to decide whether to donate, by allowing an individual responsible for the care and10 well-being of a patient to make the decision to donate. OAC 4729-35-03 (D). This includes a11 person designated by durable power of attorney or a patient’s guardian. OAC 4729-35-03 (D).12 What can be donated? See. OAC 4729-35-04. All prescription drugs, except controlled13 substances and drug samples, may be donated - provided they meet all of the following14 requirements:15 • The drugs are in their original sealed and tamper-evident unit dose packaging. OAC16 4729-35-04 (A). Pharmacy identifiers, such as labels, must be removed.17 • The drugs have been in the possession of a licensed healthcare professional only – not a18 patient. OAC 4729-35-04 (B).19 • The drugs have been stored according to Federal Food and Drug Administration storage20 requirements. OAC 4729-35-04 (C).21 • The drugs must have an expiration date of six months or greater. OAC 4729-35-04 (D).22 • The packaging must list the lot number and expiration date of the drug. OAC 4729-35-0423 (E).24 • The drugs must not have any signs of tampering or adulteration. OAC 4729-35-04 (F).25 • The drug packaging must not have any signs of tampering. OAC 4729-35-04 (G).26 • All patient information must be removed from the drug packaging. OAC 4729-35-04 (H).27 A donor form must be completed prior to any donation, and include at least these details. OAC28 4729-35-06.29 • A statement that the donor is the owner of the drug and intends to voluntarily donate the30 drug to the drug repository program. OAC 4729-35-06 (A)31 • Either the name of the person that was originally dispensed the drugs, or the name of the32 terminal distributor of dangerous drugs or wholesale distributor of dangerous drugs that33 owns the drugs. OAC 4729-35-06 (A) (1).34 • The signature of the donor (such as the person designated by durable power of attorney, a35 guardian, an individual responsible for the care and well-being of a patient, or the36 signature of the responsible person or his/her designee from a terminal distributor of37 dangerous drugs or a wholesale distributor of dangerous drugs.) OAC 4729-35-06 (A)38 (2).39 • The date the form was signed. OAC 4729-35-06 (A) (3).40
  • 7. Page 7 of 12 Additional donor information must be recorded, and may be documented on the original signed1 donor form or on an alternate record - which must include the name of the donor and:2 • The brand name of the drug donated, or the generic name and either the name of the3 manufacturer or the national drug code number (NDC#). OAC 4729-35-06 (B) (1).4 • The strength of the drug donated. OAC 4729-35-06 (B) (2).5 • The quantity of the drug donated. OAC 4729-35-06 (B) (3).6 • The date the drug was donated. OAC 4729-35-06 (B) (4).7 Eligible patients, the program’s recipients, are required to sign a recipient form stating they8 understand the immunity provisions of the drug repository program. OAC 4729-35-07. A9 significant degree of legal immunity is provided to those involved in the drug repository10 program. ORC 3715.872 (B) (1). The immunity also extends to entities that dispenses drugs11 under the program. ORC 3715.872 (B) (2). Health care professionals also enjoy this immunity,12 as do the Board of Pharmacy and the director of health. ORC 3715.872 (B) (3) and ORC13 3715.872 (B) (4). Only willful and wanton misconduct are actionable as civil matters. Drug14 manufacturers that donate are similarly immune. ORC 3715.872 (D).15 The Board has established record keeping requirements for the drug repository program. OAC16 4729-35-08. Donor forms must be maintained for a minimum of three years by a terminal17 distributor of dangerous drugs, a wholesale distributor of dangerous drugs, or an institutional18 facility. OAC 4729-35-08 (A). Recipient forms (signed by the patient) must be maintained for a19 minimum of three years by a pharmacy, hospital, or nonprofit clinic. OAC 4729-35-08 (B).20 An invoice must be created by the donor, which includes a terminal distributor of dangerous21 drugs, a wholesale distributor of dangerous drugs, or an institutional facility where the donor22 resides. OAC 4729-35-08 (C). The invoice must include at least the following information:23 • The name and address of the donor location. OAC 4729-35-08 (C) (1).24 • The brand name of the drug donated, or the generic name and list either the name of the25 manufacturer or the national drug code number (NDC#). OAC 4729-35-08 (C) (2).26 • The strength of the drug. OAC 4729-35-08 (C) (3).27 • The quantity of the drug. OAC 4729-35-08 (C) (4).28 • The date the drug was sent to a pharmacy, hospital, or nonprofit clinic. OAC 4729-35-0829 (C) (5).30 • The name and address of the recipient pharmacy, hospital, or nonprofit clinic. OAC31 4729-35-08 (C) (6).32 Prescribing and dispensing from the drug repository program inventory must be documented as33 well. OAC 4729-35-08 (D). A prescriber must document the distribution of a donated34 repository program drug to the patient. Each prescriber and terminal distributor of dangerous35 drugs must keep a record of all dangerous drugs received, administered, dispensed, distributed,36 sold, destroyed, or used. OAC 4729-9-22. This is standard record keeping for all prescription37 drug transactions. Prescribing, administering, dispensing, and destroying of dangerous drugs38 must be documented with the positive identification of the responsible individual. OAC 4729-5-39
  • 8. Page 8 of 12 01 (N). These records may be kept electronically if the method is approved by the Board and the1 records are backed-up each business day.2 • Records of receipt shall contain a description of all dangerous drugs received, the kind3 and quantity of dangerous drugs received, the name and address of the persons from4 whom received, and the date of receipt. OAC 4729-9-22 (A).5 • Records of administering, dispensing, or using dangerous drugs must contain a6 description of the kind and quantity of the dangerous drugs administered, dispensed, sold,7 or used, the date, the name and address of the patient. OAC 4729-9-22 (B).8 • Records of dangerous drug destructions, other than controlled substances, must contain9 the name, strength, dosage form, and quantity of the dangerous drug destroyed, the date10 destroyed, the method of destruction, the positive identification of the prescriber or11 responsible person that performed the destruction, and if used the positive identification12 of the person that witnessed the destruction. OAC 4729-9-22 (C).13 • All records must be kept for three years at the place where the dangerous drugs are14 located and upon request provided to a Board officer, agent, and/or inspector within three15 working days, excluding weekends and holidays. OAC 4729-9-22 (E).16 The pharmacy must document dispensing of a donated repository program drug in the same way17 dispensing is documented in any other out-patient setting. OAC 4729-5-27. Both the prescriber18 records and pharmacy records must indicate that the drug distributed to the patient was from the19 drug repository program. OAC 4729-35-08 (D). Where recipient forms are used with each20 dispensing, this information may be documented on the recipient form. OAC 4729-35-08 (D).21 A handling fee may be charged to the patient. OAC 4729-35-09. The limit for the fee is twenty22 dollars ($20.00) to cover restocking and dispensing costs. A running tally of handling fees23 collected should be maintained. The total of handling fees collected in any given year may not24 exceed the program's total restocking and dispensing costs for that given year. Thus, where25 handling fees are charged the pharmacy must also ascertain the total restocking and dispensing26 costs for any given year. By the very nature of the program, the total restocking and dispensing27 costs are not likely to be exceeded by handling fees collected from the patients for most clinics.28 Drug Donation vs Drug Takeback29 Care needs to be taken not to confuse the drug depository program, discussed in this lesson, and30 the drug takeback program – not discussed in this lesson. The pharmacist can help patients31 understand the differences.32 A complete discussion of disposing of prescription drugs and controlled substances is beyond the33 scope of this one-hour lesson. The following sections of the Ohio Administrative Code are34 directed to the subject of drug takeback (also known as prescription drug collection):35 • 4729-8-01 Definitions36 • 4729-8-02 Authorized collectors37 • 4729-8-03 Law enforcement agencies38 • 4729-8-04 Procedure for destruction of collected drugs39
  • 9. Page 9 of 12 Well-meaning patients or caregivers may show up at the pharmacy and want to donate drugs.1 They should be directed to local law enforcement authorities or the DEA for details about any2 upcoming takeback dates or drug drop box locations. To locate a prescription drug drop box3 near you: http://rxdrugdropbox.org/map-search/.4 Patients may not understand the importance of proper handling and storage of medications, and5 thus view donating medications as a sort of recycling program. To learn more about6 pharmaceutical waste management, please visit:7 http://www.deadiversion.usdoj.gov/drug_disposal/takeback/index.html.8 Additional resources are available for those wanting to learn more. The DEA published a rule on9 September 9, 2014 directed to the destruction of controlled substances. See 79 FR 53519.10 https://federalregister.gov/a/2014-20926. This rule governs the secure disposal of controlled11 substances by registrants and ultimate users. The regulations implement the Secure and12 Responsible Drug Disposal Act of 2010. Pub.L. 111-273.13 Conclusion14 The young and the indigent are recognized by lawmakers as needing additional care. Consult15 your copy of Drug Laws of Ohio or other source for additional clarification. For opioids, most16 of the new record keep requirements fall to our physician colleagues. The pharmacist is17 obligated, as always, to use professional judgment and ensure medication provided is for a18 legitimate medical purpose.19 The drug repository program is an important means of providing support for lower income20 individuals unable to pay for medication. Provided the original intended patient does not take21 possession of the medication, and the medication will not expire for at least six months, donation22 is an option to consider.23 24
  • 10. Page 10 of 12 Questions – choose the one most correct answer. A passing score is seventy percent.1 1. The new law concerning opioids for minors applies to which of the following?2 a. Oxycodone3 b. Codeine4 c. Tramadol5 d. all of the above6 2. The prescriber is exempted from discussing the potential for opioid abuse if the prescriber7 determines doing so would be a detriment for the minor’s health or safety.8 a. True9 b. false10 3. Which of the following must be discussed when prescribing opioids to a minor during an11 outpatient physician consultation?12 a. risk of overdose13 b. risk of addiction14 c. danger of use of opiates with alcohol15 d. all of the above16 4. Before prescribing opioids, the prescriber must assess whether the minor has suffered17 from all but:18 a. mental health disorder19 b. substance abuse disorder20 c. prior outpatient surgery21 d. depression22 5. All but which of the following can donate to the drug repository program:23 a. A patient whom has taken medication home from the pharmacy24 b. Pharmaceutical manufacturer25 c. Hospital26 d. Chain pharmacy27 6. The recipients of the drug repository program must:28 a. Have no reasonable financial means to pay29 b. Be a resident of the county where the clinic is located30 c. Be able to pay a fixed percentage of the prescription cost31 d. Have no prescription coverage32 7. Which of the following may not be donated to the drug repository program:33 a. alprazolam34 b. fluoxetine35 c. insulin36 d. amoxicillin powder for reconstitution37 8. The pharmacist must receive a copy of the “Start Talking!” form before filling opioid38 prescriptions for minors.39 a. True40 b. False41
  • 11. Page 11 of 12 9. Describe the relationship between dispensing handling fee and restocking and dispensing1 costs in a drug repository program dispensing location:2 a. The total of handling fees collected in any given year may exceed the program's total3 restocking and dispensing costs for that given year.4 b. The total of handling fees collected in any given year may not exceed the program's5 total restocking and dispensing costs for that given year.6 c. The total of handling fees collected for each patient may not exceed the patient’s7 total restocking and dispensing costs in any given year.8 d. None of the above.9 10. When is the prescriber limited to prescribing a seventy-two (72) hour supply of opioids?10 a. When a minor is treated in the absence of a parent or guardian11 b. When a minor is treated in an outpatient setting, such as a physician’s office12 c. When another adult authorized by the minor's parent or guardian gives the required13 consent14 d. When a minor has a history of substance abuse15 16 17
  • 12. Page 12 of 12 Lesson number 036-368-15-009-H03 Answer Sheet: Expires November 30, 20171 Approved for one contact hour of Ohio Jurisprudence by the Ohio State Board of Pharmacy2 3 Opioids to Minors and Drug Donation Programs4 Answer Sheet – circle the one correct best answer. Credit will be granted with seven correct.5 Question Answer Question Answer 1 A B C D 6 A B C D 2 True False 7 A B C D 3 A B C D 8 True False 4 A B C D 9 A B C D 5 A B C D 10 A B C D 6 Please return by mail with check for $20 payable to James Lindon at:7 James Lindon, Ph.D.8 35104 Saddle Creek, Cleveland (Avon), Ohio 44011-49079 Phone 440-333-001110 You may also send payment via PayPal to JLindon at LindonLaw dot com11 Submit answers online: http://www.lindonlaw.com/pharmacy-cpe/12 13 Please fax or e-mail, [specify one, please] my continuing education certificate to:14 Pharmacist Name ____________________________15 Street Address ________________________________________________________16 City ______________ State _______ Zip _____________17 E-Mail ___________________________________ Phone _____________________18 Ohio Pharmacist License Number _____________________19 NABP ID Number _____________________20 21 Copyright 2015 James Lindon, Lindon & Lindon LLC22 Any views expressed are not necessarily those of the author or the law firm of Lindon & Lindon.23 Program Evaluation (please circle one response to each question):24 After completing this lesson I can achieve the lesson objectives: Yes No25 This program was an effective way for me to learn: Yes No26 I liked the program’s format: Yes No27 This program fostered my mental participation: Yes No28 This was a “user-friendly” way for me to learn: Yes No29 I could sense some commercialism in this program: Yes No30 If yes, please describe: ______________________________________________31 The faculty quality was: Great OK Needs to Improve32 The learning material quality was: Great OK Needs to Improve33 How long did it take to complete this program? _______________________34 What other topics would you like to see? ____________________________35 Comments welcome: ____________________________________________36 37