Mitigating Diversion and Dispensing Naloxone

Virginia Pharmacists Association Annual Meeting

September 8, 2018

Caroline D. Juran, Executive Director

Ellen B. Shinaberry, Deputy Executive Director

Virginia Board of Pharmacy

Objectives:Upon completion of this program the participants should be able to:

1. Describe red flags associated suspicious prescriptions.

2. Understand the importance of reviewing PMP reports.

3. Understand the process for becoming a pharmacist’s delegate to PMP.

4. Describe how the Department of Health Professions utilizes PMP data to identify indiscriminant dispensing patterns.

5. Describe methods to prevent internal loss of drugs.

6. Understand the value of dispensing naloxone and the different methods by which it can be dispensed.

Public Health Impact of Opioid Analgesic Use

Treatment admissions are for primary use of opioids from Treatment Exposure Data set

Emergency department (ED) visits are from DAWN,Drug Abuse Warning Network, https://dawninfo.samhsa.gov/default.asp

Abuse/dependence and nonmedical use in the past month are from the National Survey on Drug Use and Health

Nonmedical users

People with abuse/dependence

ED visits for misuse or abuse

Abuse treatment admissions 9

For every 1 overdose death there are

35

161

461

§ 54.1-3303. (Effective until July 1, 2020) Prescriptions to be issued and drugs to be dispensed for medical or therapeutic purposes only.

A. A prescription for a controlled substance may be issued only by a practitioner of medicine, osteopathy, podiatry, dentistry or veterinary medicine who is authorized to prescribe controlled substances, or by a licensed nurse practitioner pursuant to § 54.1-2957.01, a licensed physician assistant pursuant to § 54.1-2952.1, or a TPA-certified optometrist pursuant to Article 5 (§ 54.1-3222 et seq.) of Chapter 32.

B. A prescription shall be issued only to persons or animals with whom the practitioner has a bona fide practitioner-patient relationship or veterinarian-client-patient relationship.

https://law.lis.virginia.gov/vacode/54.1-2957.01/https://law.lis.virginia.gov/vacode/54.1-2952.1/https://law.lis.virginia.gov/vacode/54.1-3222/

§ 54.1-3303. (Effective until July 1, 2020) Prescriptions to be issued and drugs to be dispensed for medical or therapeutic purposes only.

D. No prescription shall be filled unless a bona fide practitioner-patient-pharmacist relationship exists. A bona fide practitioner-patient-pharmacist relationship shall exist in cases in which a practitioner prescribes, and a pharmacist dispenses, controlled substances in good faith to a patient for a medicinal or therapeutic purpose within the course of his professional practice.In cases in which it is not clear to a pharmacist that a bona fide practitioner-patient relationship exists between a prescriber and a patient, a pharmacist shall contact the prescribing practitioner or his agent and verify the identity of the patient and name and quantity of the drug prescribed.Any person knowingly filling an invalid prescription shall be subject to the criminal penalties provided in § 18.2-248 for violations of the provisions of law relating to the sale, distribution or possession of controlled substances.

https://law.lis.virginia.gov/vacode/18.2-248/

DEA Regulations21§ C.F.R. 1306.4

• A controlled substance prescription, to be valid, must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional judgement. 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.

DEA Regulations21§ C.F.R. 1306.4

• 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…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.

Red Flags

A circumstance surrounding the presentation of a controlled substance prescription that does or should

raise a reasonable suspicion as to the validity of a prescription.

Types of Red Flags: Patient Behaviors

• Appears sedated, confused, intoxicated, withdrawal symptoms

• Poor hygiene

• Asks for drugs by street name or specific brand name

• Physical signs of drug abuse

• History of untruthfulness

• Implied or direct verbal threats

Types of Red Flags: Presentation of the Prescription

• Prescription appears to be altered or forged• Invalid DEA number• Combinations of prescriptions or known “Cocktails”• Multiple prescriptions presented, requests only controlled

substances• Similar prescriptions from multiple prescribers• Previous refusal to fill • Split payment/cash • Action against the prescriber by regulatory board or law

enforcement

Types of Red Flags: Geographical

• Distance traveled

• Out of state or “visiting”

• Travels in a group

• Same address/same medications

• Multiple prescribers/multiple pharmacies

www.dhp.virginia.gov

Virginia’s Prescription Monitoring Program (PMP) is a system in which controlled prescription drug data are collected in a database to promote the appropriate use of controlled substances for legitimate medical purposes, while deterring the misuse, abuse, and diversion of controlled substances.

PMPs:•Promote safe prescribing and dispensing practices for covered substances

•Assist law enforcement to reduce doctor shopping, drug diversion, and illegal prescribing and dispensing

•Support health profession licensing boards with licensee investigations

•Facilitate analysis of datawww.dhp.virginia.gov

Interoperability and Integration

• Interoperable with 30 state PMPs and the District of Columbia

• Over 700,000 requests from other state PMPs processed in June 2018

• Virginia PMP users made over 400,000 requests to other state PMPs in June 2018

• Integrated with 31 EMR and pharmacy software entities in Virginia

• 1.5 million requests processed in June 2018 (another million requests from out-of-state integrated entities)

www.dhp.virginia.gov

What is a Covered Substance?

§54.1-2519: As of July 1, 2018: "Covered substance" means all controlled substances included in Schedules II, III, and IV; controlled substances included in Schedule V for which a prescription is required; naloxone; and all drugs of concern that are required to be reported to the Prescription Monitoring Program, pursuant to this chapter.

www.dhp.virginia.gov

Who Must Report? Dispensers!

•Pharmacies: Resident and Non-resident

•Physicians Selling: Think Urgent Care Centers

•Dentists

•Veterinarians not applying for the legislative exemption

www.dhp.virginia.gov

VPDMP Users and Requests

www.dhp.virginia.gov

Authorized Users

• Prescribers and their delegates

• Pharmacists and their delegates

• Federal Law Enforcement

• State and Local Law Enforcement performing Drug Diversion Investigations, required training

• Health Regulatory Investigators

• Medical Examiners

• Practitioner Monitoring Program

VPDMP Requests

PMP InterConnectRequests from Other States

Integration Requests TOTAL

2012 777,269 82,496 859,765

2013 1,170,591 143,270 1,313,861

2014 1,577,194 293,002 1,870,196

2015 2,254,121 2,606,515 4,860,636

2016 3,038,504 2,439,749 1,670,417 7,148,670

2017 4,410,493 3,471,171 10,509,257 18,390,921

Requests

Why Use the PMP?

• To receive an unbiased prescription history of covered substances to inform treatment and dispensing decisions when initiating care of a patient

• To monitor compliance with the patient’s treatment plan and to ensure coordination of care with covered substances

www.dhp.virginia.gov

Narx Care

Code of VA §54.1-2523.2 Authority to access database

Any prescriber or dispenser authorized to access the information in the possession of the Prescription Monitoring Program pursuant to this chapter may, pursuant to regulations promulgated by the Director to implement the provisions of the section, delegate such authority to individuals who are employed or engaged at the same facility and under the direct supervision of the prescriber or dispenser and (i) are licensed, registered, or certified by a health regulatory board under the Department of Health Professions or in another jurisdiction or (ii) have routine access to confidential patient data and have signed a patient data confidentiality agreement.

Becoming a PMP Delegate

Log on to PMP website: https://virginia.pmpaware.net

Select the appropriate delegate role

Enter supervisor’s email for verification.

User will receive email confirmation once account is approved

https://virginia.pmpaware.net/

Criteria for indicators of misuse; Director’s authority to disclose information; intervention.

§ 54.1-2523.1 - A. The Director shall develop, in consultation with an advisory panel which shall include representatives of the Boards of Medicine and Pharmacy, criteria for indicators of unusual patterns of prescribing or dispensing of covered substances by prescribers or dispensers and misuse of covered substances by recipients and a method for analysis of data collected by the Prescription Monitoring Program using the criteria for indicators of misuse to identify unusual patterns of prescribing or dispensing of covered substances by individual prescribers or dispensers or potential misuse of a covered substance by a recipient.

PMP Criteria: Top 10 Dispensers

•Preliminary investigation

•PMP data generated for 3-month period

• Identify possible index patients using defined criteria

•Change to full investigation or close case

Top 10 Dispensers: A Closer Look at the Numbers

• Prescriptions

• Patients

• Doses

• Prescribers

• Distances

Top 10 Dispensers: Other Considerations

• Bona fide practitioner-patient-pharmacist relationship

• Pharmacy demographics

• Naloxone

• Early refill requests

• Payment method

• Travel triad

• PMP queries by pharmacists

• Round 1:• 1 or more patient over 2,000 MME• 10 or more patients over 1,000 MME

• Round 2:• 1 patient over 2,000 MME• 5 patients over 750 MME• 25 patients over 500 MME

PMP Criteria: Morphine Milligram Equivalency

Recent Changes to Review & Reporting of PMP Data in Virginia

• HB 311 and SB 728 amended § 54.1-2523.1

• Key changes:

• Directs an annual review of prescribing and dispensing patterns

• Provides for expansion of Advisory Panel

• Calls for changes to criteria

• Report findings and recommendations for best practices

Internal Diversion - Case Examples

• Will Call

• Skimming

• ADDs

• Waste

• Substituting medications

• Remote stock

• Ordering/receiving

Preventing Internal DiversionBOP GD 110-27 Responsibilities of the Pharmacist in Charge

Suggested Best Practices for Preventing Diversion

• Background checks

• License lookup

• Random urine drug screening

• Prohibit bags/purses/backpacks in prescription department

• Monitor manual adjustments to inventory of CS

• Monitor ordering of CS

• Security and inventory of expired CS

• Will call/return to stock

Naloxone• Reverses opioid overdose

• Overdose could be from prescription opioid, heroin, or illicit opioid

• 2013/2014:

• General Assembly passed § 54.1-3408(X) authorizing pilot program to expand access to naloxone

Naloxone• 2015:

• General Assembly amended § 54.1-3408(X) authorizing pharmacies across state to dispense naloxone pursuant to an oral, written, or standing order in accordance with Board-approved protocol, in consultation with Board of Medicine and VDH

• person could administer naloxone to another person believed to be experiencing an opioid overdose

• provided liability protections for those involved

• authorized law enforcement and firefighters to possess and administer naloxone

Naloxone• November 2016:

• Health Commissioner, Dr. Levine, declared a public health emergency and issued a statewide standing order

• All pharmacists may now dispense naloxone pursuant to this statewide standing order

• Standing order amended February 2017 to modify Evzio strength now available

• Amended in 2018 under new Health Commissioner – Norman Oliver, MD

• Electronic copy available from Board of Pharmacy –pharmbd@dhp.Virginia.gov

mailto:pharmbd@dhp.Virginia.gov

Board-Approved Naloxone Protocol for Pharmacist Dispensing

• Guidance Document 110-44 found at www.dhp.Virginia.gov/pharmacy

• Specifies elements prescriber must include in a standing order;

• Mandates pharmacist counseling unless person provides documentation of successful completion of REVIVE! training program

• Specifies subjects to cover during counseling:

http://www.dhp.virginia.gov/pharmacy

Summary: How Can Pharmacists Dispense Naloxone?

1. Request copy of Commissioner’s statewide standing order by emailing Board of Pharmacy and maintain on file -pharmbd@dhp.Virginia.gov

2. Familiarize yourself with Board-approved naloxone protocol –www.dhp.Virginia.gov/pharmacy

3. Download copy of DBHDS brochure and make copies to handout when dispensing naloxone – www.dhp.Virginia.gov/pharmacy

4. Identify patients at risk for overdose and recommend obtaining naloxone and/or dispense upon request

mailto:pharmbd@dhp.Virginia.govhttp://www.dhp.virginia.gov/pharmacyhttp://www.dhp.virginia.gov/pharmacy

Summary: How Can Pharmacists Dispense Naloxone?

5. Determine which formulation may be covered by person’s insurance.

6. Label naloxone pursuant to Board-approved protocol (may redact name, if desired).

7. Counsel patient as required in Board-approved protocol unless documentation provided indicating completion of REVIVE! training program

Naloxone Dispensing by Certain REVIVE! Trainers

• 2017 law further expanded – §54.1-3408(Y)

• DBHDS-approved REVIVE! Trainers in community settings may dispense naloxone to persons who have successfully completed training program

• Must be acting on behalf of organization providing services to individuals at risk of experiencing an opioid overdose or training in the administration of naloxone

• Organization must obtain controlled substances registration (CSR) certificate from Board

• Naloxone stored at site with CSR when not dispensing in community

• Protocol for Trainers found in Guidance Document 110-45

Questions?