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Best Practices for Prescribing, Dispensing, and Preventing Opioid Drug Diversion

Best Practices for Prescribing, Dispensing, and Preventing Opioid Drug Diversion

Scott Kjelson Pharm. D., CPh. NSU College of Pharmacy

Director of Student TransitionsAssistant Professor

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Special Guest: Susan Langston Diversion Program Manager

Drug Enforcement Administration

Speakers Disclosure Speakers Disclosure Scott Kjelson and Susan Langston do not have a vested interest or an affiliation with any corporation or organization offering financial support or grant monies for this seminar

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The information here is solely for educational purposesThe content of this presentation provides a general overview of the regulatory requirements.

Pharmacists and Technicians should review state and federal regulatory statutes for a complete description of compliance requirements.

Our discussion does not constitute legal, risk, or accreditation advice. No warranty is made, expressed or implied, with respect to this presentation and any liability resulting from any use or reliance on this event is disclaimed.

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Special AcknowledgementsSpecial Acknowledgements• Kathleen Baldwin Pharm.D., BCPS, FSHP Past President • Charzetta James Pharm.D., FSHP Immediate Past

President• Mark Mikhael Pharm.D., Board of Pharmacy• Norman Tomaka BS. Pharm., MS • Jim Hall Epidemiologist, United Way Broward CRT• Angela Ventura- United Way Broward CRT

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Pharmacist Objectives Pharmacist Objectives 1. Evaluate how to identify fraudulent prescriptions, drug-seeking behaviors, and drug diversion within inpatient and outpatient settings.

2. Analyze risk reduction approaches.

3. Develop best practices for preventing drug diversion.

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Technician Objectives Technician Objectives 1. Discuss the identification of fraudulent prescriptions and

drug diversion within inpatient and outpatient settings.

2. Describe risk reduction approaches.

3. Given a patient case, apply best practices for preventing drug diversion.

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SystematicFailure

OPIOIDSOPIOIDS• “The U.S. has 4% of the world’s population and consumes 63% of the world’s

illegal drugs.” ‘America’s Worst Drug Epidemic’ 2013 Seminar Robert M. Stutman (Former DEA Supervisory Agent)

• “USA with 5% of population consumes 80% of opioids and 95% of Vicodin in the world.” (Institute of Addiction Medicine)

• 146 deaths a day in 2016 – Jim Hall • 14 deaths a day including 27 overdoses in 2016• More than 4000 babies born with neonatal abstinence syndrome

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Diversion Diversion • Drug diversion can be defined as any act or deviation that removes a

prescription drug from its intended path from the manufacturer to the patient. It involves the diversion of drugs from legal and medically necessary uses towards uses that are illegal and typically not medically authorized or necessary.

• According to the Mayo Clinic, up to 15 percent of healthcare workers have addictions to drugs or alcohol, compared to 8 percent of the general population. This leads to diversion and drug seeking behavior.

• Happens in-patient and out-patient both by patients and professionals

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KEY NOTEKEY NOTE

If you have controls….

YOU WILL HAVE DIVERSION

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Diversion- The Main Issues Diversion- The Main Issues • Lack of communication • Lack of relationships • Lack of resources• Systematic failures• Lack of oversite and surveillance • Lack of education • Lack of Social Determinants • Trusting the “TEAM”• Lack of proper training

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“Community pharmacists repeatedly cited having their supplies or shipments of controlled substances abruptly shut off by their

wholesalers, which may have done so due to perceived pressure, intimidation or a lack of clear guidance from law enforcement officials, such as the Drug Enforcement Administration (DEA),”

said B. Douglas Hoey, CEO of NCPA, which represents over 23,000 independent pharmacies across the United States.

Diversion Diversion • How many health systems have Controlled

Substance (CS) diversion prevention programs??

• Where are all my diversion officers??

• Opioid Stewardship? Why not Pain??

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Diversion- The In-patient Solutions Diversion- The In-patient Solutions ASHP Guidelines on Preventing Diversion of Controlled Substances

Interdisciplinary committee members should have clear roles

• Medicine, • Anesthesia, • Pharmacy, • Nursing, • Security, • Human resources,

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• Compliance, • Risk management, • Administration, • Legal, • Media/communications,• Information technology, • Employee health.

Diversion- The In-patient Solutions Diversion- The In-patient Solutions ASHP Guidelines on Preventing Diversion of Controlled Substances

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A comprehensive human resources approach to support the CSDPP include

• A written employee and provider substance abuse policy, • An HCW education and awareness program• A supervisor training program,• An employee and provider assistance program, • Peer support and systems (e.g., pharmacist recovery networks), • Requirements for drug testing, including a for-cause policy for drug testing, • Return-to-work policies for HCWs,• Sanctions for performance and diversion violations.

Diversion In MotionDiversion In MotionAll systems of control should be regularly audited for compliance on a scheduled basis.

The Pharmacist should lead in development

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Diversion- Utilizing Technology Diversion- Utilizing Technology

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Diversion- Prevent TamperingDiversion- Prevent Tampering

• Return unused medication to a separate return bin, not stock, for inspection.

• Keep controlled substances secure (use tamper evident caps on infusions).

• Use serialized locks during transport and on kits.

• Confirm integrity by checking inventories, counts, and administration.

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Diversion- Speaking up

An All Hands on Deck Approach

Diversion- Speaking up

An All Hands on Deck Approach

• Training and signs

• Protection

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Diversion- Patient ConversationsDiversion- Patient Conversations• Maintain clear conversation and build report with

both the patient and family• Risk Assessment• Request updates of pain management• Investigate normal patterns outside the hospital to

ensure social attributes will not lead to abuse or diversion

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Diversion- Transitions of CareDiversion- Transitions of CareIt’s just as important to properly treat as it is to follow-up with treatment

• Contact patient and pharmacy in which patient is using to ensure proper communication and details are met• Could be done through case management

• Document and provide communication to all providers• Family history and information to ensure safe keeping of meds (lockbox)• Provide resources and means to find additional resources when leaving

the hospital including • Contact information to the pharmacy• Websites that could provide (Drug takebacks)• Medication information

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Diversion- PDMP and UpdatesDiversion- PDMP and UpdatesE-FORCSE Requirements

The E-FORCSE must be queried by the prescriber and dispenser, or the designee of a prescriber or dispenser before prescribing and dispensing ANY controlled substance, including acute and non-acute pain for any patients 16 years or older unless it is a non-opioid controlled schedule V drug. Schedule III, IV and V only at initial prescription (not refills). Dispensing practitioners must report controlled substances dispensed no later than the close of the next business day and must consult the E-FORCSE prior to dispensing.

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Diversion- Technology Advancements Diversion- Technology Advancements The PDMP is collaborating with Appriss Health, the service provider for E-FORCSE, to provide this integration option to all health care practitioners in Florida utilizing a service called PMP Gateway. The PMP Gateway facilitates communication, information transfer, integration, and support for the state approval process and the EHR vendor development process. Eventually will allow INTERSTATE SHARING

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Diversion- Disposal Diversion- Disposal GAO found that about 3 percent of pharmacies and other entities eligible to collect unused prescription drugs for disposal have volunteered to do so. About half of the people who reported misusing prescription drugs in 2015 received them from a friend or relative. (The Grandma Effect)

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Diversion- Drug Take Back Diversion- Drug Take Back

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Diversion- COMMUNITYDiversion- COMMUNITYCVS HEALTH • 1,650 safe medication disposal sites added to CVS Pharmacy and

Community locations• Nearly 3 million patients received enhanced opioid safe use

counseling from CVS Pharmacists over the past five months• Nearly 400,000 teens and parents educated on prescription drug

abuse prevention through the company's community education program, Pharmacists Teach

• All 9,800 CVS Pharmacy locations launching enhanced Naloxone patient education following the Surgeon General's 2018 Advisory

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Diversion- COMMUNITYDiversion- COMMUNITYUM- IDEA PROGRAM (NEEDLE EXCHANGE)

• The program has received over 170,000 needles since opening

• The program has distributed more than 1,000 doses of naloxone

• Provides free hepatitis C and HIV testing.• Provides Resources for mental and behavioral

health

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Diversion- Drug Seeking Behavior Diversion- Drug Seeking Behavior • Drug-seeking patients appear to exhibit “classically” described

drug-seeking behaviors with only low to moderate frequency. Reliance on historical features may be inadequate when trying to assess whether or not a patient is drug-seeking.

• Can mimic normal signs of a patient in pain• Anxiety• Stressed out• Eager to get out of the pharmacy• Upset• Loud

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Diversion- Drug Seeking Behavior Diversion- Drug Seeking Behavior

• Why motivational intervention is so important• Why education is so important• Not just asking “Do you have any questions

for the pharmacists”• Why the DRIVE-THROUGH is the death of us.

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Diversion- Drug Seeking Behavior Diversion- Drug Seeking Behavior • Drug-seeking patients appear to exhibit “classically” described

drug-seeking behaviors with only low to moderate frequency. Reliance on historical features may be inadequate when trying to assess whether or not a patient is drug-seeking.

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Diversion-Drug Seeking Signs Diversion-Drug Seeking Signs • Claiming to have lost a prescription or have had a prescription stolen• Claims of needing a specific narcotic, because they are allergic to or

otherwise unable to take non-narcotics• Describing a list of “textbook” symptoms• Patient not from town of pharmacy• Exaggerating the severity of symptoms• Exhibiting signs of drug abuse, including withdrawal symptoms or skin

tracks• Frequent visits to different out-of-town doctors

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Diversion-Drug Seeking Signs Diversion-Drug Seeking Signs • Frequent visits to emergency rooms with complaints of pain, anxiety, or

other symptoms the sought-after drug can relieve• Going to two or more doctors within a short period of time in an effort

to get a specific drug (sometimes referred to as “doctor shopping”)• Not interested in an actual diagnosis, but still wants specific drugs• Unwilling or unable to provide medical records or contact information

about previous doctors• Inconsistencies in story

• (WHY COUNCILING IS SO IMPORTANT x 3 months for chronic care)

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Diversion- Fraud Diversion- Fraud • Understand drug seekers will always be ahead of

the system

• Drug seekers will venture from ER to pharmacy looking for physicians and pharmacists to miss a step

• Drug seekers can obtain access to stolen prescription pads

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Diversion- Fraud Diversion- Fraud Resolve the red flags

• Verify the prescription is valid and for a legitimate medical need • Verify the prescription is appropriate for the medical need • Verify the prescriber and their office • Verify PDMP

BEFORE YOU REJECT A PATIENT START WITH WHAT YOU KNOW

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Florida Statutes, Standards of practice

Before dispensing a controlled substance to a person not known to the pharmacist, the pharmacist must require the person purchasing, receiving, or otherwise acquiring the controlled substance to present valid photographic identification or other verification of his or her identity. If the person does not have proper identification, the pharmacist may verify the validity of the prescription and the identity of the patient with the prescriber or his or her authorized agent.

Diversion- Fraud HB-21 Diversion- Fraud HB-21 Diversion- Fraud Diversion- Fraud 64B16-27.831 Standards of Practice for the Filling of Controlled Substance Prescriptions;

1. Initiate communication with the patient or the patient’s representative to acquire information relevant to the concern with the validity of the prescription,2. Initiate communication with the prescriber or the prescriber’s agent to acquire information relevant to the pharmacist’s concern with the validity of the prescription.

(b) In lieu of either subparagraph 1. or 2., but not both, the pharmacist may elect to access the Prescription Drug Monitoring Program’s Database

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GREEN FLAGS FIRST GREEN FLAGS FIRST

• Patient is honest upon communication• Prescriber is known and writes for others • Patient has chronic pain/ appropriate disease • Has had an opioid prescription before

COMMUNICATION IS KEY! DO NOT DENY SO YOU DON’T HAVE TO DEAL WITH IT

ACCESS TO CARE!!!

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Diversion- Addiction RiskDiversion- Addiction RiskKeep in mind there are people that are dealing with

outside factors that get addicted. Watching a movie high on drugs may make the movie better and then lead to an

increase in use because now the mall is more fun, the work is easier to handle, the relationship doesn’t seem

that bad, the kids are easier to deal with.

YOU HAVE AN OPPORTUNITY TO INTERVENE AND PROVIDE RESOURCES

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Patient Case Patient Case

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SP is a 42 YOF that had a slip and fall accident 3 weeks ago. She presents to your pharmacy today with a chief complaint hip and back pain. The patient has refused alternative therapy and has a new prescription for an opioid. She states this is the only thing that works and she wont leave until she gets her med. Pt shows signs of irritation, refuses any counseling before being offered, and is from a town over 50 miles away. Pt’s story seems really hard to believe and has many inconsistencies when simple questions are being asked. Pt also states she likes how she feels when she is on opioids

WOULD YOU??A. Say you do not have the opioid available and refuse to fill?B. Contact her physician and try to validate?C. Would you contact local law enforcement?

PANEL DISCUSSION

THANK YOU!

PANEL DISCUSSION

THANK YOU!

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