Disclosures. Learning Objectives. Pharmacy Law Topics. Spring Seminar 2017

Transcription

1 Spring Seminar 2017 prescribing authority Controlled substance Privacy Pharmacy Law Topics Charlie Mollien, PharmD, JD, MS Director of Pharmacy Compliance & Privacy Officer Meijer Disclosures Charlie Mollien has no conflicts of interest or financial interest to disclose. Activity type: knowledge-based Pharmacists Association is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Learning Objectives 1. Review the 2016 and 2017 changes to the Public Health Code and Administrative Code that change midlevel prescribing authority. 2. Discuss the Controlled Substances Act requirements for a prescriber to issue a valid controlled substance prescription and the pharmacist s corresponding responsibility. 3. Review how the Health Insurance Portability and Accountability Act permits disclosure of Protected Health Information.

2 prescribing authority prescribing authority DELEGATION PRACTICE AGREEMENT 2016 rule changes 2017 law changes prescribing authority Delegated prescribing of controlled substances before December 2016 PHYSICIAN ASSISTANT Delegation to prescribe controlled substances allowed under MD, DO, and DPM Limited scope of practice Based on delegation agreement Indicate names (and DEA numbers for controlled substances) of PA and supervising physician on controlled all PA used supervising physician s controlled substance to prescribe PA must have his or her own DEA registration number NURSE PRACTITIONER/ NURSE MIDWIFE Delegation to prescribe controlled substances allowed under MD and DO Limited scope of practice CII s may only be prescribed for patients discharged from or located within a freestanding surgical outpatient facility, hospital, or hospice CII limited to a 7-day supply NP/NMW used supervising physician s controlled substance to prescribe NP/NMW must have his or her own DEA registration number For NP/NMW delegation, see MAC r (DO), (MD). For PA delegation, see MAC r (DO), (MD), (DPM). Differences between PA and NP/NMW delegation in blue font.

3 prescribing authority MAC r Delegation of prescribing controlled substances to nurse practitioners or nurse midwives; limitation. (1) A physician may delegate the prescription of controlled substances listed in schedules 2 to 5 to a registered nurse who holds specialty certification under section of the code, MCL , with the exception of a nurse anesthetist, if the delegating physician establishes a written authorization that contains all of the following information: (a) The name, number, and signature of the delegating physician. (b) The name, number, and signature of the nurse practitioner or nurse midwife. (c) The limitations or exceptions to the delegation. (d) The effective date of the delegation. (2) A delegating physician shall review and update a written authorization on an annual basis from the original date or the date of amendment, if amended. A delegating physician shall note the review date on the written authorization. (3) The delegating physician shall ensure that an amendment to the written authorization is in compliance with subrule (1) of this rule. (4) A delegating physician shall maintain the signed, written authorization at the delegating physician s primary place of practice. (5) The delegating physician shall provide a copy of the signed, written authorization to the nurse practitioner or nurse midwife. (6) A delegating physician shall not authorize a nurse practitioner or a nurse midwife to issue a prescription for a schedule 2 controlled substance with a quantity greater than a 30-day supply. (7) A delegating physician shall not delegate the prescription of a drug or device individually, in combination, or in succession for a woman known to be pregnant with the intention of causing either a miscarriage or fetal death. Board of Osteopathic Medicine and Surgery. prescribing authority MAC r Delegation of prescribing controlled substances to nurse practitioners or nurse midwives; limitation. (1) A physician may delegate the prescription of controlled substances listed in schedules 2 to 5 to a registered nurse who holds specialty certification under section of the code, MCL , with the exception of a nurse anesthetist, if the supervising physician establishes a written authorization that contains all of the following information: (a) The name, number, and signature of the supervising physician. (b) The name, number, and signature of the nurse practitioner or nurse midwife. (c) The limitations or exceptions to the delegation. (d) The effective date of the delegation. (2) The supervising physician shall review and update a written authorization on an annual basis from the original date or the date of amendment, if amended. The supervising physician shall note the review date on the written authorization. (3) The supervising physician shall maintain a written authorization at the supervising physician s primary place of practice. (4) The supervising physician shall provide a copy of the signed, written authorization to the nurse practitioner or nurse midwife. (5) The supervising physician shall ensure that an amendment to the written authorization is in compliance with subrules (1), (2), (3), and (4) of this rule. (6) A supervising physician shall not authorize a nurse practitioner or a nurse midwife to issue a prescription for a schedule 2 controlled substance with a quantity greater than a 30-day supply. (7) A supervising physician shall not delegate the prescription of a drug or device individually, in combination, or in succession for a woman known to be pregnant with the intention of causing either a miscarriage or fetal death. Board of Medicine. prescribing authority Delegation PHYSICIAN ASSISTANT Superseded by law changing definition of practice as a physician s assistant and prescriber in the Public Health Code. NURSE PRACTITIONER/ NURSE MIDWIFE Written delegation agreement between MD and NMW, NP, or clinical nurse specialist (not nurse anesthetists) NP or NMW may not issue a schedule 2 prescription with a quantity greater than a 30-day supply. NP/NMW s may never prescribe drugs with intent to cause miscarriage or fetal death For NP/NMW delegation, see MAC r (DO), (MD). For PA delegation, see MAC r (DO), (MD), (DPM). MAC r and do not include clinical nurse specialists.

4 PHYSICIAN ASSISTANT PA s are independent prescribers. Delegation is not allowed. Must have a practice agreement with: MD to practice medicine as a PA. DO to practice osteopathic medicine and surgery as a PA. DPM to practice pediatric medicine and surgery as a PA. prescribing authority Delegation For PA s, delegation now allowed. See MCL (MD), (DO), and (DPM) for practice agreement requirements. prescribing authority Practice agreements PHYSICIAN ASSISTANT to practice as a physician assistant Written agreement between MD and PA, limited to duties and responsibilities within PA s scope of education, training, or experience LARA may restrict drugs or drug classes that a PA may not prescribe Independent prescribing authority for all medications ADVANCED PRACTICE RN to practice as an APRN Nurse midwife Nurse practitioner Clinical nurse specialist Independent prescribing authority for non-scheduled prescription drugs May prescribe controlled substances by delegation Rx must include the name and DEA number for both the APRN and supervising MD/DO For NP/NMW practice agreement, see MCL a. For PA practice agreement, see MCL (MD), (DO), and (PDM). prescribing authority current as of April 9, 2017 Prerequisites to prescribe medicine Prescriptive authority (subject to scope of practice) Dispensing issued out-of-state Controlled substance /registration Scope of practice Practice Agreement Delegation Prescribe nonscheduled (indicate supervising physician on Rx) medicine Prescribe controlled substances non-scheduled Controlled substance controlled substance DEA number MD, DO Unlimited N/A N/A Yes Yes for issued in DVM/VMD Animals N/A N/A (animals only) (animals only) Yes Yes for issued in DDS/DMD Mouth N/A N/A Yes Yes for issued in OD Eye Must have therapeutic pharmaceutical agent (TPA) certification Always required DPM Hand*, Foot, Ankle N/A N/A Always required PA Based on practice agreement N/A (based practice agreement) (based practice agreement) Always required NP, NMW, Clinical Nurse Specialist Based on practice agreement to prescribe controlled substances (based practice agreement), up to 30 days supply (must also have supervising physician s DEA number on Rx) (May use MD/DO ) *DPM scope for hands is limited to examination, diagnosis, and treatment of abnormal nails and superficial excrescenses, including warts and callosities.

5 prescribing authority current as of April 9, 2017 Scope of practice Prerequisites to prescribe medicine Practice Agreement Delegation (indicate supervising physician on Rx) Prescriptive authority (subject to scope of practice) Prescribe nonscheduled medicine Prescribe controlled substances Dispensing issued out-of-state non-scheduled Controlled substance Controlled substance /registration controlled substance DEA number MD, DO Unlimited N/A N/A Yes Yes for issued in DVM/VMD Animals N/A N/A (animals only) (animals only) Yes Yes for issued in DDS/DMD Mouth N/A N/A Yes Yes for issued in OD Eye Must have therapeutic pharmaceutical agent (TPA) certification Always required DPM Hand*, Foot, Ankle N/A N/A Always required PA Based on practice agreement N/A (based practice agreement) (based practice agreement) Always required NP, NMW, Clinical Nurse Specialist Based on practice agreement to prescribe controlled substances (based practice agreement), up to 30 days supply (must also have supervising physician s DEA number on Rx) (May use MD/DO ) *DPM scope for hands is limited to examination, diagnosis, and treatment of abnormal nails and superficial excrescenses, including warts and callosities.

6 Controlled substance DEA 161 DEA 161R DEA 236 DEA 357 DEA 189 DEA 250 DEA 488 Quotas, Imports, Exports PDMP reverse distributor DEA 106 DEA 41 DEA 222 DEA e222 DSCSA (DQSA Title II) ARCOS ARCOS Controlled substance License and registration requirements to prescribe controlled substances

7 DEA 189 DEA 250 DEA 488 (DQSA Title II) DSCSA DEA 161 DEA 161R DEA 236 DEA 357 ARCOS DEA 41 reverse distributor Quotas, Imports, Exports ARCOS DEA 106 PDMP DEA 222 DEA e222

8 License and registration requirements to prescribe controlled substances MD, DO, DDS/DMD, DPM, DVM/VMD, OD, and PHYSICIAN ASSISTANT MICHIGAN: Must obtain a controlled substance (CS) and USA: Must have an active DEA registration certificate with authority to prescribe drug schedule CII n-narcotic CII Narcotic CIII n-narcotic CIII Narcotic CIV CV ADVANCED PRACTICE RN MICHIGAN: May use MD/DO CS through delegation; must also indicate supervising physician s name and DEA number on CS USA: Must have an active DEA registration certificate with authority to prescribe drug schedule CII n-narcotic CII Narcotic CIII n-narcotic CIII Narcotic CIV CV prescriber, as defined under MCL , practicing within the state of must have a controlled substance ( MCSL ) to prescribe controlled substances. A MCSL is not required for out-of-state controlled substance issued by MD s, DO s, DDS/DMD s, and DVM/VMD s. All other out-of-state prescribers, as recognized under law, must also have a MCSL for controlled substance to be dispensed by a pharmacy in the state of. Controlled substance Anatomy of a valid prescription E. Beltline SE, Grand Rapids, MI FD Tel: (616) E 8 Owner: John Smith 7 5 Name Rascal Smith (canine) Address 1 NE Grand Rapids, MI and over Xanax 1 mg tab 14 #5 (five) Sig: 1 po daily PRN fireworks 15 Refills NR E Jane Doe, DVM 17 Jane Doe Signature 2 10 Do not fill until 6/7/17 DOB Date 9 5/9/ Prescriber s printed name (For APRN s, include supervising physician name and DEA number for CS s) Prescriber s professional designation Prescriber s address Prescriber s DEA registration number Patient s full name Patient s address, or owner s address if patient is an animal If patient is an animal, species If patient is an animal, owner s full name Date issued 10 Do not fill until date Drug name Drug strength Drug form Quantity (written Rx must have numerical and written or checked box/line quantity) Directions for use Refill indication (zero refills if not on Rx) Prescriber s signature (written) Prescriber s electronic signature (e-rx) Electronically prescribed controlled substances must also include prescriber s electronic signature, telephone number, name of pharmacy Rx sent to, date and time of transmission, and whether substitution permissible. 2 9

9 SENT TO: ABC PHARMACY #1 DATE SENT: 5/9/2017 AT 11:37:00 AM DATE WRITTEN: 5/8/2017 A8982K2I92KLSD9824 PATIENT: JOHN SMITH BIRTHDATE: 1/1/1975 ADDRESS: 1 MICHIGAN NE GRAND RAPIDS, MI DRUG: AMBIEN 5 MG TABLET QUANTITY: 30 DIRECTIONS: 1 TAB PO HS PRN, 30 MIN BEFORE DAYS SUPPLY: 30 REFILL: 0 E MAY SUBSTITUTE 10 COMMENT: DO NOT FILL UNTIL 6/5/2017 PRESCRIBER ELECTRONICALLY SIGNED BY JANE DOT, F-NP 1810 E. BELTLINE SE, GRAND RAPIDS, MI FD TEL: (616) SUPERVISING PHYSICIAN JASON WATCHDOG, MD BW TRANSMITTED BY: AGENT AMY E 1 E Prescriber s printed name (For APRN s, include supervising physician name and DEA number for CS s) Prescriber s professional designation Prescriber s address Prescriber s DEA registration number Patient s full name Patient s address, or owner s address if patient is an animal If patient is an animal, species If patient is an animal, owner s full name Date issued Drug name Drug strength Drug form Quantity (written Rx must have numerical and written or checked box/line quantity) Directions for use Refill indication (zero refills if not on Rx) Prescriber s signature (written) Prescriber s electronic signature (e-rx) 10 Do not fill until date Electronically prescribed controlled substances must also include prescriber s electronic signature, telephone number, name of pharmacy Rx sent to, and date and time of transmission. 9 Controlled substance Corresponding responsibility Controlled substance A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of section 309 of the Act (21 U.S.C. 829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances. 21 CFR The DEA refers to the pharmacist s corresponding responsibility as the last line of defense.

10 Controlled substance RED FLAGS A red flag is a level of concern that might cause a pharmacist to either choose not to fill a prescription or take some other kind of actions and the more red flags there are, the stronger that suspicion is. A pharmacist is required to resolve red flags before dispensing the controlled substance prescription. Holiday CVS, L.L.C., d/b/a CVS/Pharmacy s. 219 and 5915; Decision and Order. FR (citing 21 CFR (a)). Controlled substance RED FLAGS Controlled substances are high alert drugs and among controlled substances, drugs such as opioids, benzodiazepines, and other central nervous system depressant drugs require the highest level of scrutiny on the part of a pharmacist who is presented with for these drugs. Simply calling a doctor's office to verify that he or she wrote a prescription does not meet the requirement [of verification]." Holiday CVS, L.L.C., d/b/a CVS/Pharmacy s. 219 and 5915; Decision and Order. FR (citing 21 CFR (a)). Controlled substance RED FLAGS Many customers: A. Receiving the same combination of ; B. Receiving the same strength of controlled substances; C. Paying cash for their ; D. With the same diagnosis codes written on their ; E. With controlled substance written by physicians not associated with pain management (i.e., pediatricians, gynecologists, ophthalmologists, etc.) Prescriptions that result in therapeutic conflicts Individuals driving long distances to visit physicians and/or to fill Customers coming to the pharmacy in groups, each with the same issued by the same physician Hill, Robert L. Drug Enforcement Administration. Prescription Drug Abuse. Available at: pharm_awareness/conf_2014/april_2014/hill.pdf#search=red%20flags. Last accessed April 22, 2017.

11 Controlled substance RED FLAGS Paying for controlled substance with cash or using discount cards Respective locations of the patient and the prescriber Prescriber writes for certain combinations or patterns of drugs Multiple patients present for the same drugs and the same quantities from the same doctor without variability (suggesting the prescribing is done in a factory like manner Combinations of drugs (e.g. alprazolam and oxycodone) because both drugs are commonly diverted Prescribing oxycodone 15 mg and 30 mg tablets together Holiday CVS, L.L.C., d/b/a CVS/Pharmacy s. 219 and 5915; Decision and Order. FR (citing 21 CFR (a)). Controlled substance RED FLAGS Evaluate each individual prescription. Don t use preset limits. The pharmacist limited the number of the store would fill each day even though the pharmacy still had oxycodone in inventory. The prescription limit was set to keep some inventory for real pain patients. The pharmacist s opinion was that "as a pharmacist she was stuck between a rock and a hard place, and that basically * * * she had not been trained to diagnose," and that if she or her staff were "able to confirm that a prescription had been issued by a physician who was d by the state, and had a DEA, then... [the pharmacy] should be able to trust that that prescription--or that physician is legitimate, and that the doctor * * * ha[d] given the correct diagnosis." Holiday CVS, L.L.C., d/b/a CVS/Pharmacy s. 219 and 5915; Decision and Order. FR (citing 21 CFR (a)). Privacy

12 M I N I M U M N E C E S S A R Y R U L E Permitted Uses and Disclosures 1. To the individual. 2. Treatment, payment, and operations. 3. Uses and disclosures with opportunity to object. 4. Incidental use and disclosure. 5. Public interest and benefit activities. 6. Limited data set. Authorized Uses and Disclosures 1. Authorization. 2. Psychotherapy notes. 3. Marketing. Uses and Disclosures 1. To the individual (or their personal representative) when requesting A. Access to PHI B. Accounting of disclosures of PHI 2. To HHS for a(n) A. Compliance investigation B. Enforcement action Controlled substance DECEASED PATIENT RECORDS HIPAA survives death PHI is protected for 50 years following death Medical records/phi of the deceased patient may be released to: Spouse, parent, child, domestic partner, other relatives or friends of decedent if that person was involved in the decedent s health care or payment for care prior to death Covered entity must continue to honor any restrictions or the disclosure is inconsistent with known prior expressed preferences Personal representative (the person with legal authority to act on behalf of the decedent or decedent s estate, such as the estate executor/ administrator or individual with health care power of attorney) Law enforcement, but only to alert individual s death if suspected cause of death is criminal conduct Coroners or medical examiners and funeral directors Research that is solely on the PHI of the decedent Organ procurement organizations that procure, bank, or transplant cadaveric organs, eyes, or tissue to facilitate organ, eye, or tissue donation and transplantation Contact information Charlie Mollien 2929 Walker Ave NW Grand Rapids, MI Charlie.Mollien@meijer.com

13 Which of the following prescribers does not require a Controlled Substance License to prescribe a schedule IV controlled substance? a. PA b. NP c. MD d. DO e. none of the above Which of the following prescribers may not enter into a practice agreement with a midlevel PA or advanced practice registered nurse? a. Ophthalmologist b. Rheumatologist c. Podiatrist d. Dermatologist e. All of the above may enter into a practice agreement In, A schedule III controlled substance prescription issued by an appropriately d advanced practice registered nurse under the supervision of a medical doctor may be issued for up to a day supply and refills. a. 7, 5 b. 7, 0 c. 30, 5 d. 30, 0 e. 90, 1

14 The widow of patient John Doe may obtain a copy of the deceased John's prescription fill history if she presents John's death certificate listing her as the spouse at the time of his death. further documentation is required. a. True b. False