Opioids to Minors and Drug Donation Programs Objectives By completing the lesson, the pharmacist will be able to:

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1 Opioids to Minors and Drug Donation Programs Objectives By completing the lesson, the pharmacist will be able to: Discuss Ohio s new laws concerning use of opioids in minors Describe the documents and record keeping for opioid prescriptions Discuss Ohio s 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. Prescribing of Opioids to Minors The U.S. Food and Drug Administration approved OxyContin for children as young as eleven () years old on August, 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 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: 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 1.01 (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 1.01 (B)() o The risks of addiction and overdose associated with opioid analgesics; ORC 1.01 (B)()(a) o The increased risk of addiction to controlled substances of individuals suffering from both mental and substance abuse disorders; ORC 1.01 (B)()(b) o The dangers of taking opioid analgesics with benzodiazepines, alcohol, or other central nervous system depressants; ORC 1.01 (B)()(c) o Any other information in the patient counseling information section of the labeling for the opioid analgesic required under 1 C.F.R. 01.(c)(1). ORC 1.01 (B)()(d). Page 1 of

2 Note: 1 C.F.R. 01.(c)(1) 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 1.01 (B)(). The prescriber must also record this consent on a form, known as the "Start Talking!" consent form. ORC 1.01 (B)(). 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 1.01 (B)()(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 1.01 (B)()(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 1.01 (B)(); ORC 1.01 (B)()(c) o The number of refills, if any, authorized by the prescription; ORC 1.01 (B) ()(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 1.01 (B)()(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 1.01 (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 1.01 (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 1.01 (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 1.01 (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, Page of

3 pediatric respite care program, residential care facility, freestanding rehabilitation facility, or similar institutional facility. ORC 1.01 (D) Limits. No more than a seventy-two () 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 1.01 (E). For example, if the parents give written authorization to consent to medical treatment to a child s Aunt, the prescriber can prescribe no more than a seventy-two () 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 minor s medical record. ORC 1.01 (F). Defined as an opioid analgesic as of March 01. ORC 1.01 Generic Name Brand Name Schedule Buprenorphine BUTRANS, BUPRENEX Schedule III Butorphanol BUTORPHANOL NS Schedule IV Codeine (acetaminophen and other combination products) Dihydrocodeine/ASA/caffei ne Fentanyl TYLENOL W. CODEINE #, TYLENOL W. CODEINE # SYNALGOS-DC DURAGESIC, ACTIQ, ABSTRAL, LAZANDA, FENTORA, SUBSYS, SUBLIMAZE, ONSOLIS, IONSYS Schedule III Schedule III 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 IBUDONE, REPREXAIN, VICOPROFEN Schedule II (October, 01) Hydrocodone (ibuprofen Schedule II combination products) 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, PERCODAN, PERCOCET, ROXICET, Schedule II aspirin and other combination products) ENDOCET, XOLOX, TYLOX, PRIMLEV, MAGNACET, XARTEMIS XR Oxymorphone OPANA, NUMORPHAN Schedule II Tapentadol NUCYNTA Schedule II Tramadol ULTRAM, ULTRACET, RYZOLT, CONZIP, RYBIX Schedule IV (August 1, 01) Page of

4 Role of the Pharmacist 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: 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 prescriber s office, the patient s or caregiver s residence, or a caregiver s 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. Page of

5 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 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: The Ohio State Legislature has established a drug repository program for donated prescription drugs. ORC 1.. 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 --0 (B)(1) and -- 0 (B)(). Drugs donated to the program and dispensed must be in their original sealed and tamper-evident packaging ORC 1. (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 1. (B)(). A drug will not be accepted or dispensed if there is reason to believe it is adulterated. ORC 1. (B)(). Perhaps the most common way for a drug to be considered adulterated is when the drug s 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 1. (A)(). Oral cancer drugs are treated differently. ORC 1. (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 1. (D). Controlled substances are not considered oral cancer drugs for these purposes. The criteria from the legislature for donating prescription drugs to the drug repository program is quite broad. Any person can donate. ORC 1.1 (A). Likewise, a drug manufacturer or health care facility (such as a hospital or nursing home) may also donate. ORC. (I)(1) and ORC. (I)(). The drugs must be donated at an approved pharmacy, hospital, or nonprofit clinic that volunteers to participate in the drug repository program. ORC 1.1 (A). Donated drugs may not be resold, though a handling fee may be charged. ORC 1.1 (B). Page of

6 The Board further clarified that a person electing to donate must not have taken custody of the drug prior to the donation. OAC --0 (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 --0 (C) and OAC --0. The donor form must state from this day forward I wish to donate all my remaining unused drugs that are eligible, pursuant to rule --0 of the Administrative Code, to the drug repository program. The Board s 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 --0 (D). This includes a person designated by durable power of attorney or a patient s guardian. OAC --0 (D). What can be donated? See. OAC --0. All prescription drugs, except controlled substances and drug samples, may be donated - provided they meet all of the following requirements: The drugs are in their original sealed and tamper-evident unit dose packaging. OAC --0 (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 --0 (B). The drugs have been stored according to Federal Food and Drug Administration storage requirements. OAC --0 (C). The drugs must have an expiration date of six months or greater. OAC --0 (D). The packaging must list the lot number and expiration date of the drug. OAC --0 (E). The drugs must not have any signs of tampering or adulteration. OAC --0 (F). The drug packaging must not have any signs of tampering. OAC --0 (G). All patient information must be removed from the drug packaging. OAC --0 (H). A donor form must be completed prior to any donation, and include at least these details. OAC --0. A statement that the donor is the owner of the drug and intends to voluntarily donate the drug to the drug repository program. OAC --0 (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 --0 (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 --0 (A) (). The date the form was signed. OAC --0 (A)(). Page of

7 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 --0 (B)(1). The strength of the drug donated. OAC --0 (B)(). The quantity of the drug donated. OAC --0 (B)(). The date the drug was donated. OAC --0 (B)(). Eligible patients, the program s recipients, are required to sign a recipient form stating they understand the immunity provisions of the drug repository program. OAC --0. A significant degree of legal immunity is provided to those involved in the drug repository program. ORC 1. (B)(1). The immunity also extends to entities that dispenses drugs under the program. ORC 1. (B)(). Health care professionals also enjoy this immunity, as do the Board of Pharmacy and the director of health. ORC 1. (B)() and ORC 1. (B)(). Only willful and wanton misconduct are actionable as civil matters. Drug manufacturers that donate are similarly immune. ORC 1. (D). The Board has established record keeping requirements for the drug repository program. OAC --0. 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 --0 (A). Recipient forms (signed by the patient) must be maintained for a minimum of three years by a pharmacy, hospital, or nonprofit clinic. OAC --0 (B). 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 --0 (C). The invoice must include at least the following information: The name and address of the donor location. OAC --0 (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 --0 (C)(). The strength of the drug. OAC --0 (C)(). The quantity of the drug. OAC --0 (C)(). The date the drug was sent to a pharmacy, hospital, or nonprofit clinic. OAC --0 (C)(). The name and address of the recipient pharmacy, hospital, or nonprofit clinic. OAC --0 (C)(). Prescribing and dispensing from the drug repository program inventory must be documented as well. OAC --0 (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 --. 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 -- Page of

8 (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 -- (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 -- (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 -- (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 -- (E). 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 --. Both the prescriber records and pharmacy records must indicate that the drug distributed to the patient was from the drug repository program. OAC --0 (D). Where recipient forms are used with each dispensing, this information may be documented on the recipient form. OAC --0 (D). A handling fee may be charged to the patient. OAC --0. The limit for the fee is twenty dollars ($0.00) 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. Drug Donation vs Drug Takeback 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. 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): --01 Definitions --0 Authorized collectors --0 Law enforcement agencies --0 Procedure for destruction of collected drugs Page of

9 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: 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: Additional resources are available for those wanting to learn more. The DEA published a rule on September, 01 directed to the destruction of controlled substances. See FR 1. 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 0. Pub.L. 1-. Conclusion 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. 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. Page of

10 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. The prescriber is exempted from discussing the potential for opioid abuse if the prescriber determines doing so would be a detriment for the minor s health or safety. a. True b. false. 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. 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. 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. 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. Which of the following may not be donated to the drug repository program: a. alprazolam b. fluoxetine c. insulin d. amoxicillin powder for reconstitution. The pharmacist must receive a copy of the Start Talking! form before filling opioid prescriptions for minors. a. True b. False Page of

11 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 patient s total restocking and dispensing costs in any given year. d. None of the above.. When is the prescriber limited to prescribing a seventy-two () 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 physician s 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 1 Page of

12 Lesson number H0 Answer Sheet: Expires November 0, 01 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 A B C D True False A B C D A B C D True False A B C D A B C D A B C D A B C D Please return by mail with check for $0 payable to James Lindon at: James Lindon, Ph.D. Saddle Creek, Cleveland (Avon), Ohio 0-0 Phone You may also send payment via PayPal to JLindon at LindonLaw dot com Submit answers online: Please fax or , [specify one, please] my continuing education certificate to: Pharmacist Name Street Address City State Zip Phone Ohio Pharmacist License Number NABP ID Number Copyright 01 James Lindon, Lindon & Lindon LLC Any views expressed are not necessarily those of the author or the law firm of Lindon & Lindon. Program Evaluation (please circle one response to each question): After completing this lesson I can achieve the lesson objectives: Yes No This program was an effective way for me to learn: Yes No I liked the program s format: Yes No This program fostered my mental participation: Yes No This was a user-friendly way for me to learn: Yes No I could sense some commercialism in this program: Yes No If yes, please describe: The faculty quality was: Great OK Needs to Improve The learning material quality was: Great OK Needs to Improve How long did it take to complete this program? What other topics would you like to see? Comments welcome: Page of

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