opioids to minors and drug donation programs

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Opioids to Minors and Drug Donation Programs 1

Objectives 2

By completing the lesson, the pharmacist will be able to: 3

• Discuss Ohio’s new laws concerning use of opioids in minors 4

• Describe the documents and record keeping for opioid prescriptions 5

• Discuss Ohio’s donated drug repository program 6

• Describe record keeping for drug repository program 7 8

Introduction 9

As pharmacists, we are aware that prescriptions for children receiving opioid analgesics require 10

special attention. Ohio recently enacted new laws concerning use of opioid analgesics. While 11

most of the burdens fall on the prescriber, pharmacists need to be aware of these changes to 12

address questions about the law and understand the requirements. Ohio law also provides for 13

donation of prescription drugs to treat economically disadvantaged persons. While these 14

medications are in some sense “free” they come with record keeping requirements to assure 15

medication integrity. This lesson will discuss the law in these subjects. 16

Prescribing of Opioids to Minors 17

The U.S. Food and Drug Administration approved OxyContin for children as young as eleven 18

(11) years old on August 13, 2015. http://www.fda.gov/drugs/newsevents/ucm456973.htm. The 19

use of OxyContin among children is not something new. However the rules directed to 20

prescribing of opioids to minors are relatively new revisions to Ohio law. ORC 3719.061. The 21

law creates a duty on the prescriber to do certain things before issuing to a minor the first 22

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 ever 24

suffered, or is currently suffering, from mental health or substance abuse disorders and 25

whether the minor has taken or is currently taking prescription drugs for treatment of 26

those disorders; ORC 3719.061 (B) (1) 27

• Discuss with the minor and the minor's parent, guardian, or another adult authorized to 28

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; ORC 30

3719.061 (B) (2) (a) 31

o The increased risk of addiction to controlled substances of individuals suffering 32

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 other 34

central nervous system depressants; ORC 3719.061 (B) (2) (c) 35

o Any other information in the patient counseling information section of the 36

labeling for the opioid analgesic required under 21 C.F.R. 201.57(c)(18). ORC 37

3719.061 (B) (2) (d). 38

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� Note: 21 C.F.R. 201.57(c)(18) is directed to information necessary for 1

patients to use a drug safely and effectively (e.g., precautions concerning 2

driving or the concomitant use of other substances that may have harmful 3

additive effects). 4

• The prescriber must also obtain written consent for the prescription from the minor's 5

parent, guardian, or, subject to division (E) of this section, another adult authorized to 6

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 other 9

document the prescriber uses to obtain informed consent for other treatment provided to 10

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 of 12

the initial dose; ORC 3719.061 (B) (3) (a) 13

o A statement indicating that a controlled substance is a drug or other substance that 14

the United States drug enforcement administration has identified as having a 15

potential for abuse; ORC 3719.061 (B) (3) (b) 16

o A statement certifying that the prescriber discussed with the minor and the 17

minor's parent, guardian, or another adult authorized to consent to the minor's 18

medical treatment the matters described in ORC 3719.061 (B) (2); ORC 3719.061 19

(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 to 23

consent to the minor's medical treatment and the date of signing. ORC 3719.061 24

(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. ORC 28

3719.061 (C) (1) (a) 29

o The treatment is associated with or incident to surgery, regardless of whether the 30

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 division 33

(B) of this section with respect to the minor's treatment would be a detriment to 34

the minor's health or safety. ORC 3719.061 (C) (1) (c) 35

o The treatment is rendered in a hospital, emergency facility, ambulatory surgical 36

facility, nursing home, pediatric respite care program, residential care facility, 37

freestanding rehabilitation facility, or similar institutional facility. ORC 3719.061 38

(C) (1) (d) 39

� Note: The discussion and form ARE NEEDED when the minor is treated 40

in a prescriber's office, even if located on the premises of, or adjacent to, a 41

hospital, emergency facility, ambulatory surgical facility, nursing home, 42

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pediatric respite care program, residential care facility, freestanding 1

rehabilitation facility, or similar institutional facility. ORC 3719.061 (D) 2

• Limits. No more than a seventy-two (72) hour supply of a controlled substance 3

containing an opioid may be prescribed when another adult authorized by the minor's 4

parent or guardian gives the required consent. ORC 3719.061 (E). For example, if the 5

parents give written authorization to consent to medical treatment to a child’s Aunt, the 6

prescriber can prescribe no more than a seventy-two (72) hour supply of hydrocodone for 7

the child when the Aunt takes the child for treatment. The Aunt has less authority to 8

consent than the parent or custodial guardian. 9

• The “Start Talking!” form must be maintained in the minor’s medical record. ORC 10

3719.061 (F). 11

Defined as an opioid analgesic as of March 2015. ORC 3719.01 12

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

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Role of the Pharmacist 1

Of course, the pharmacist should always use professional judgment before dispensing any 2

medication, particularly controlled substances. Some common sense points for the pharmacist to 3

keep in mind include: 4

• Pharmacists should be prepared to assure parents of young patients that presenting a copy 5

of the “Start Talking!” form to the pharmacist is not legally required to fill a legitimate 6

prescription. 7

• Pharmacists should be prepared to communicate that the form is an important part of the 8

education process for proper use of opioids. 9

• Pediatric patients with legitimate prescriptions should be treated with the same 10

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 and 14

treatment of pain. 15

• If the pharmacist believes that the patient and the caregiver were somehow not included 16

in a discussion with the prescriber about proper use of opioids, the pharmacist should 17

consider an appropriate discussion of: 18

o The risks of addiction and overdose associated with opioid analgesics 19

o The increased risk of addiction to controlled substances of individuals suffering 20

from either mental and substance abuse disorders 21

o The dangers of taking opioid analgesics with benzodiazepines, alcohol, or other 22

central nervous system depressants 23

o Any other information necessary for patients to use the medication safely and 24

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, the 26

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’s 29

residence, or a caregiver’s place of work. 30

• Very high doses of opioids being prescribed for young patients. Though pediatric 31

patients develop tolerance like any patient, comparatively smaller body weights of 32

pediatric patients are also to be considered. 33

• Opiates being prescribed for very young patients for very long periods of time. There 34

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 the 37

prescriber has a very specialized practice, the quantity of opioid prescription from any 38

given prescriber should be fairly similar to colleagues in that type of practice. 39

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• Prescribers issuing prescriptions that may be outside of their scope of practice. The 1

pharmacist may expect that a specialist, such as a pediatric oncologist, might prescribe 2

more opioids for children than a cardiologist. 3

Drug Repository Program for Donated Prescription Drugs 4

Community pharmacists are well aware of the economic pressure in daily practice. It would be 5

rare indeed for the pharmacist not to have some sort of discussion with a patient about 6

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 be 8

found online at: 9

• http://ohiofreeclinics.org/ 10

• http://ohiofreeclinics.org/who-we-are/locations/find-a-clinic.html 11

The Ohio State Legislature has established a drug repository program for donated prescription 12

drugs. ORC 3715.87. The purpose of the program is to provide medication to be dispensed to 13

individuals who are residents of Ohio and meet eligibility standards established in rules adopted 14

by the Board. Basically, the recipient must have “no reasonable financial means to pay for the 15

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-evident 18

packaging ORC 3715.87 (B) (1). The packaging must be unopened, except that drugs packaged 19

in single unit doses may be accepted and dispensed when the outside packaging is opened if the 20

single unit dose packaging is undisturbed. ORC 3715.87 (B) (2). A drug will not be accepted or 21

dispensed if there is reason to believe it is adulterated. ORC 3715.87 (B) (3). Perhaps the most 22

common way for a drug to be considered adulterated is when the drug’s strength differs from, or 23

its quality or purity falls below, the standard set forth in accepted references, such as United 24

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 require 26

refrigeration, freezing, or storage at a special temperature may be accepted and dispensed even if 27

not in original sealed and tamper-evident unit dose packaging. Oral cancer drugs must pass a 28

“basic visual inspection” that the drugs appear to be unadulterated, safe, and suitable for 29

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 is 32

quite broad. Any “person” can donate. ORC 3715.871 (A). Likewise, a drug manufacturer or 33

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, or 35

nonprofit clinic that volunteers to participate in the drug repository program. ORC 3715.871 36

(A). Donated drugs may not be resold, though a handling fee may be charged. ORC 3715.871 37

(B). 38

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The Board further clarified that a person electing to donate must not have taken custody of the 1

drug prior to the donation. OAC 4729-35-03 (B). The person may direct the donation through a 2

terminal distributor of dangerous drugs, such as a participating community pharmacy. This 3

requirement ensures proper storage conditions and handling – that may not be provided if the 4

person takes the drugs home. Also, persons in nursing homes, may elect to sign and date a donor 5

form prior to donating a drug. OAC 4729-35-03 (C) and OAC 4729-35-06. The donor form 6

must state “from this day forward I wish to donate all my remaining unused drugs that are 7

eligible, pursuant to rule 4729-35-04 of the Administrative Code, to the drug repository 8

program.” The Board’s regulation also permits donation in cases where the patient may not be 9

competent to decide whether to donate, by allowing an individual responsible for the care and 10

well-being of a patient to make the decision to donate. OAC 4729-35-03 (D). This includes a 11

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 controlled 13

substances and drug samples, may be donated - provided they meet all of the following 14

requirements: 15

• The drugs are in their original sealed and tamper-evident unit dose packaging. OAC 16

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 a 18

patient. OAC 4729-35-04 (B). 19

• The drugs have been stored according to Federal Food and Drug Administration storage 20

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 4729-35-04 23

(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. OAC 28

4729-35-06. 29

• A statement that the donor is the owner of the drug and intends to voluntarily donate the 30

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 the 32

terminal distributor of dangerous drugs or wholesale distributor of dangerous drugs that 33

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, a 35

guardian, an individual responsible for the care and well-being of a patient, or the 36

signature of the responsible person or his/her designee from a terminal distributor of 37

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

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Additional donor information must be recorded, and may be documented on the original signed 1

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 the 3

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 they 8

understand the immunity provisions of the drug repository program. OAC 4729-35-07. A 9

significant degree of legal immunity is provided to those involved in the drug repository 10

program. ORC 3715.872 (B) (1). The immunity also extends to entities that dispenses drugs 11

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 ORC 13

3715.872 (B) (4). Only willful and wanton misconduct are actionable as civil matters. Drug 14

manufacturers that donate are similarly immune. ORC 3715.872 (D). 15

The Board has established record keeping requirements for the drug repository program. OAC 16

4729-35-08. Donor forms must be maintained for a minimum of three years by a terminal 17

distributor of dangerous drugs, a wholesale distributor of dangerous drugs, or an institutional 18

facility. OAC 4729-35-08 (A). Recipient forms (signed by the patient) must be maintained for a 19

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 dangerous 21

drugs, a wholesale distributor of dangerous drugs, or an institutional facility where the donor 22

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 the 25

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 4729-35-08 29

(C) (5). 30

• The name and address of the recipient pharmacy, hospital, or nonprofit clinic. OAC 31

4729-35-08 (C) (6). 32

Prescribing and dispensing from the drug repository program inventory must be documented as 33

well. OAC 4729-35-08 (D). A prescriber must document the distribution of a donated 34

repository program drug to the patient. Each prescriber and terminal distributor of dangerous 35

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 prescription 37

drug transactions. Prescribing, administering, dispensing, and destroying of dangerous drugs 38

must be documented with the positive identification of the responsible individual. OAC 4729-5-39

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01 (N). These records may be kept electronically if the method is approved by the Board and the 1

records are backed-up each business day. 2

• Records of receipt shall contain a description of all dangerous drugs received, the kind 3

and quantity of dangerous drugs received, the name and address of the persons from 4

whom received, and the date of receipt. OAC 4729-9-22 (A). 5

• Records of administering, dispensing, or using dangerous drugs must contain a 6

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 contain 9

the name, strength, dosage form, and quantity of the dangerous drug destroyed, the date 10

destroyed, the method of destruction, the positive identification of the prescriber or 11

responsible person that performed the destruction, and if used the positive identification 12

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 are 14

located and upon request provided to a Board officer, agent, and/or inspector within three 15

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 way 17

dispensing is documented in any other out-patient setting. OAC 4729-5-27. Both the prescriber 18

records and pharmacy records must indicate that the drug distributed to the patient was from the 19

drug repository program. OAC 4729-35-08 (D). Where recipient forms are used with each 20

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 twenty 22

dollars ($20.00) to cover restocking and dispensing costs. A running tally of handling fees 23

collected should be maintained. The total of handling fees collected in any given year may not 24

exceed the program's total restocking and dispensing costs for that given year. Thus, where 25

handling fees are charged the pharmacy must also ascertain the total restocking and dispensing 26

costs for any given year. By the very nature of the program, the total restocking and dispensing 27

costs are not likely to be exceeded by handling fees collected from the patients for most clinics. 28

Drug Donation vs Drug Takeback 29

Care needs to be taken not to confuse the drug depository program, discussed in this lesson, and 30

the drug takeback program – not discussed in this lesson. The pharmacist can help patients 31

understand the differences. 32

A complete discussion of disposing of prescription drugs and controlled substances is beyond the 33

scope of this one-hour lesson. The following sections of the Ohio Administrative Code are 34

directed to the subject of drug takeback (also known as prescription drug collection): 35

• 4729-8-01 Definitions 36

• 4729-8-02 Authorized collectors 37

• 4729-8-03 Law enforcement agencies 38

• 4729-8-04 Procedure for destruction of collected drugs 39

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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 any 2

upcoming takeback dates or drug drop box locations. To locate a prescription drug drop box 3

near you: http://rxdrugdropbox.org/map-search/. 4

Patients may not understand the importance of proper handling and storage of medications, and 5

thus view donating medications as a sort of recycling program. To learn more about 6

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 on 9

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 controlled 11

substances by registrants and ultimate users. The regulations implement the Secure and 12

Responsible Drug Disposal Act of 2010. Pub.L. 111-273. 13

Conclusion 14

The young and the indigent are recognized by lawmakers as needing additional care. Consult 15

your copy of Drug Laws of Ohio or other source for additional clarification. For opioids, most 16

of the new record keep requirements fall to our physician colleagues. The pharmacist is 17

obligated, as always, to use professional judgment and ensure medication provided is for a 18

legitimate medical purpose. 19

The drug repository program is an important means of providing support for lower income 20

individuals unable to pay for medication. Provided the original intended patient does not take 21

possession of the medication, and the medication will not expire for at least six months, donation 22

is an option to consider. 23

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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. Oxycodone 3 b. Codeine 4 c. Tramadol 5 d. all of the above 6

2. The prescriber is exempted from discussing the potential for opioid abuse if the prescriber 7 determines doing so would be a detriment for the minor’s health or safety. 8 a. True 9 b. false 10

3. Which of the following must be discussed when prescribing opioids to a minor during an 11 outpatient physician consultation? 12 a. risk of overdose 13 b. risk of addiction 14 c. danger of use of opiates with alcohol 15 d. all of the above 16

4. Before prescribing opioids, the prescriber must assess whether the minor has suffered 17 from all but: 18 a. mental health disorder 19 b. substance abuse disorder 20 c. prior outpatient surgery 21 d. depression 22

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 pharmacy 24 b. Pharmaceutical manufacturer 25 c. Hospital 26 d. Chain pharmacy 27

6. The recipients of the drug repository program must: 28 a. Have no reasonable financial means to pay 29 b. Be a resident of the county where the clinic is located 30 c. Be able to pay a fixed percentage of the prescription cost 31 d. Have no prescription coverage 32

7. Which of the following may not be donated to the drug repository program: 33 a. alprazolam 34 b. fluoxetine 35 c. insulin 36 d. amoxicillin powder for reconstitution 37

8. The pharmacist must receive a copy of the “Start Talking!” form before filling opioid 38 prescriptions for minors. 39 a. True 40 b. False 41

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9. Describe the relationship between dispensing handling fee and restocking and dispensing 1 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 total 3 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's 5 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’s 7 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 guardian 11 b. When a minor is treated in an outpatient setting, such as a physician’s office 12 c. When another adult authorized by the minor's parent or guardian gives the required 13 consent 14 d. When a minor has a history of substance abuse 15

16

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Lesson number 036-368-15-009-H03 Answer Sheet: Expires November 30, 2017 1 Approved for one contact hour of Ohio Jurisprudence by the Ohio State Board of Pharmacy 2 3

Opioids to Minors and Drug Donation Programs 4

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 44011-4907 9 Phone 440-333-0011 10 You may also send payment via PayPal to JLindon at LindonLaw dot com 11

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

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E-Mail ___________________________________ Phone _____________________ 18

Ohio Pharmacist License Number _____________________ 19

NABP ID Number _____________________ 20

21 Copyright 2015 James Lindon, Lindon & Lindon LLC 22 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 No 25 This program was an effective way for me to learn: Yes No 26 I liked the program’s format: Yes No 27 This program fostered my mental participation: Yes No 28 This was a “user-friendly” way for me to learn: Yes No 29 I could sense some commercialism in this program: Yes No 30 If yes, please describe: ______________________________________________ 31 The faculty quality was: Great OK Needs to Improve 32 The learning material quality was: Great OK Needs to Improve 33 How long did it take to complete this program? _______________________ 34 What other topics would you like to see? ____________________________ 35 Comments welcome: ____________________________________________ 36 37

opioids to minors and drug donation programs

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