Objectives 1/25/18. An Update on Controlled Substance Prescribing Laws & Rules for CNMs. Exclusionary Formulary Effective: May 17, 2017

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1 1/25/18 An Update on Controlled Substance Prescribing Laws & Rules for CNMs Keeley Harding, DNP, APRN, CPNP-AC/PC February 4, Ohio ACNM Forward Kalahari Resorts and Conference Center, Sandusky, Ohio Objectives Interpret the state laws and rules pertaining to CNMs who prescribe controlled substances Describe prescribing guidelines for the safe and effective use of controlled substances Exclusionary Formulary Effective: May 17,

2 Is Your DEA Registration Valid? New Limits on Prescription Opioids for Acute Pain Effective Date: August 31, 2017 See Handout ( of the OAC) New Limits on Prescription Opioids for Acute Pain CONTINUED Does not apply to: Inpatient prescriptions Cancer and associated conditions Palliative care End-of-life/Hospice care Medication-Assisted Treatment (MAT) for addiction 2

3 New Limits on Prescription Opioids for Acute Pain CONTINUED Extended-release or long-acting opioids shall not be prescribed Non-opioid treatment options must be considered first Opioids may only be prescribed following an H&P that determines the need for the Rx New Limits on Prescription Opioids for Acute Pain CONTINUED The patient has been advised of the benefits and risks of the opioid, including the potential for addiction THIS MUST BE DOCUMENTED IN THE PATIENT S RECORD New Limits on Prescription Opioids for Acute Pain CONTINUED The presumption is a 3-day supply or less is frequently sufficient No more than a 7-day supply of opioids may be prescribed for adults (with no refills) No more than a 5-day supply of opioids may be prescribed for minors (with no refills), and only after the written consent of the parent or guardian is obtained (see Handout) 3

4 ORC New Limits on Prescription Opioids for Acute Pain CONTINUED The 7-day and 5-day limits may be exceeded for pain expected to persist for a longer period of time as long as a 30 MED average per day is maintained AND the APRN documents in the patient s record the reason for exceeding the time and why a non-opioid medication is not appropriate Exceptions to the 30 MED Average per Day Prescription for Acute Pain Effective Date: January 1, 2018 The patient suffers from a medical condition, surgical outcome, or injury of such severity that pain cannot be managed within an average of 30 MED per day such as: Traumatic crushing of tissue; Amputation; Major orthopedic surgery; Severe burns AND 4

5 Exceptions to the 30 MED Average per Day Prescription for Acute Pain Effective Date: January 1, 2018 The treating physician for the condition has entered into an SCA with the APRN Note: The SCA does not require the treating physician to supervise the APRN and does not constitute a delegation of prescriptive authority to the APRN The APRN documents in the patient s record the reason for exceeding the 30 MED average and the reason it is the lowest dose consistent with the patient s medical condition Exceptions to the 30 MED Average per Day Prescription for Acute Pain Effective Date: January 1, 2018 The SCA must document the understanding between the APRN and the treating physician as to: (a) when the APRN prescriber may exceed the 30 MED average; and (b) whether the APRN prescriber must consult with the physician prior to exceeding the 30 MED average, and if consultation is required, when it is required SCA Example An APRN has an SCA with all physicians in a facility orthopedic surgical unit, signed by the unit director or chair as the designated representative. The SCA includes an exhibit specifying conditions in which the APRN may exceed the 30 MED average following major orthopedic surgery of such severity that pain cannot be managed within the 30 MED average limits as determined based on prevailing standards of medical care, including which conditions and circumstances require treating physician consultation, and which do not. The APRN prescriber must follow the SCA regarding the parameters set forth for prescribing and consultation. 5

6 ICD-10 Diagnosis Code Requirement Effective Date: December 29, 2017 Must include, at a minimum, the first four alphanumeric characters (e.g., M16.5) of the ICD-10 medical diagnosis code or procedure code on for opioid analgesic prescriptions Code is entered by the pharmacy into OARRS Effective Date is June 1, 2018 for non-opioid analgesic controlled substance prescriptions and OAC Days Supply on Rx Requires prescribers, including CNMs, to indicate the days supply on all controlled substance and products containing Gabapentin and OAC Faxed Prescriptions A recent amendment to Pharmacy Board Rule makes changes to the requirements for faxed prescriptions Except in limited circumstances, prescribers can no longer transmit prescriptions using a transmission system that converts the prescription into a computer-generated fax or scanned image For more information on the exceptions, see HANDOUT 6

7 Safety Standards for Personally Furnishing Controlled Substances Effective Date: January 1, 2018 Limited to a 72-hour supply Must not exceed 2,500 dosage units (in any 30-day period) Samples must be provided free of charge Must be labeled and packaged in accordance with state & federal drug laws and any rules and regulations Maintain a written record of all drugs personally furnished and ORC; and OAC House Bill 216 CONTROLLED SUBSTSANCE Rx Related Provisions Effective Date: April 6, 2017 Applicant may apply for a CNM license up to 5 years after completing 45 hours of advanced pharmacology (previously, 3 years) Collaborating physician may collaborate with up to 5 CNMs (previously, no more than 3) , , , , and ORC House Bill 216 CONTROLLED SUBSTSANCE Rx Related Provisions Effective Date: April 6, 2017 Schedule II Certain Conditions Any physician can issue the patient s initial Rx (previously, was only the CNM s collaborating physician) May prescribe an amount for the patient s use in a single 72-hour period (previously, it was 24-hours) May issue a prescription from a residential care facility location ORC 7

8 Ohio Automated Rx Reporting System (OAARS) See Handout OAC Standard Care Agreement (SCA) & Quality Assurance (QA) Provisions for the use of schedule II controlled substances If prescribing to minors, provisions for complying with section of ORC when prescribing an opioid analgesic to a minor Provisions for OARRS reports, and engaging in physician consultation and patient care and OAC Standard Care Agreement (SCA) & Quality Assurance (QA) A procedure for the CNM and the collaborating physician, or a designated member of a QA committee, composed of at least one physician, of the institution, organization, or agency where the CNM has practiced during the period covered by the review, to conduct a periodic review, at least semiannually, of: (i) A representative sample of prescriptions written by the CNM (ii) A representative sample of schedule II prescriptions written by the CNM and OAC 8

9 Delegating to Unlicensed Personnel Prohibited from delegating the administration of controlled substances (C) and ORC; OAC ORC; OAC Naloxone CNM may personally furnish a supply of Naloxone, or issue a prescription for Naloxone, without having examined the individual to whom it may be administered if both of the following conditions are met: (1) Issued to and in the name of a family member, friend, or other individual in a position to assist an individual who there is reason to believe is at risk of experiencing an opioid-related overdose AND ORC; OAC 9

10 Naloxone (2) Instructs the individual to summon emergency services as soon as practicable either before or after administering naloxone to an individual apparently experiencing an opioidrelated overdose DOCUMENT, DOCUMENT, DOCUMENT!!! ORC; OAC Naloxone A CNM who in good faith furnishes a supply of Naloxone or issues a prescription for Naloxone is not liable for or subject to any of the following for any action or omission of the individual to whom the naloxone is furnished or the prescription is issued: damages in any civil action, prosecution in any criminal proceeding, or professional disciplinary action ORC; OAC 10

11 1/25/18 Walmart Pharmacy & DisposeRx Environmental Safe Method to Dispose of Drugs 11

12 Resources Ohio Perinatal Quality Collaborative (OPQC) Neonatal Abstinence Syndrome & Maternal Addiction Project: Substance Abuse and Mental Health Services Administration (SAMHSA): DEA Drug Addiction in Health Care Professionals: Ohio Prescribing Guidelines: Centers for Disease Control & Prevention (CDC) Guidelines, Training, & Other Opioid Prescribing Resources: Turning the Tide on the Opioid Crisis: Project DAWN (Deaths Avoided with Naloxone): References Ohio Revised Code (ORC) or the Nurse Practice Act Chapter 4723: Ohio Administrative Code (OAC) or the Nursing Rules Chapter 4723: 12