Controlled Substances (CS) - PowerPoint Presentation

Slide1

Controlled Substances (CS)and CS for the Treatment of PainUse, Misuse, Abuse, Tolerance, Dependence, and AddictionWhat Do We Do Now?

Joe Hardy, MD

Associate Professor of Primary Care

Touro

University Nevada

Nevada State Senator, District 12Slide2

Disclosures and DisclaimersFull-time Associate Professor Touro University of Nevada, College of Osteopathic Medicine since Nov. 1, 2012Nevada State Senator District #12 since 2010Member AAFP, NAFP, CCMS,NSMAFellow ABFMVeteran USAF, MajorNo other outside income affiliations31.5 hours of CME since Nov. 28th on Addictions and TreatmentsSlide3

ObjectivesUnderstand scope of opioid overdose crisisDefinition of tolerance, addiction, substance use disorderUnderstand how Nevada’s PMP fits into standard of careMedication-assisted Treatment (MAT) optionsDifferentiate MAT (Methadone clinic and Buprenorphine options)Explain role of naloxone in MAT and in emergency useHow to obtain a DATA 2000 waiver to do Buprenorphine MATOther options than controlled substancesSlide4

NBME Prohibited Professional ConductNAC 630.230 (Oct. 11, 1999 thru July 19, 2000)NAC 630.230

Prohibited professional conduct

. (NRS 630.130, 630.275)

1.

A person who is

licensed as a

physician

or physician's assistant

shall not

:

(m)

Fail to adequately prescribe controlled substances for the control of pain

in accordance with

prevailing standards of acceptable practice of medicine as described in NAC 630.193

; or

(n)

Engage in the practice of writing prescriptions for controlled substances

to treat acute or chronic pain in a manner

that deviates from

the

prevailing standards of acceptable practice of medicine as described in NAC 630.193.Slide5

STANDARD OF CAREPROCEDURE FOR PRESCRIBING CONTROLLED SUBSTANCESNAC 630.193NAC 630.193

Controlled substances for acute or chronic pain: Procedure for prescribing

1.

A physician

and a physician's assistant

SHALL CONTROL

ANY

acute or chronic

PAIN

of a patient

for the duration of the pain

b

y prescribing controlled substances

in accordance with

the prevailing standards of acceptable practice of medicine as described in subsection 2.

2.

To comply with the prevailing standards of acceptable practice of medicine

,

the physician

or physician's assistant

SHALL

:

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(a) BEFORE PRESCRIBING the controlled substance

:

(1) Conduct an assessment and evaluation of the patient that includes, without limitation:

(I) A

physical examination

;

(II) Investigation and documentation of the

medical history

of the patient; and

(III)

Investigation of whether the patient has a history of substance abuse

;

(2)

Establish a plan for treating the patient

that includes, without limitation:

(I)

Objectives

that will be used

to determine the success of the treatment

, including, without limitation, the objectives of pain relief and improved physical and psychosocial function;

(II)

A list and timetable for diagnostic evaluations and other treatments that are planned for the patient

; and

(III)

An agreement between the physician

or physician's assistant and the patient

that the patient will obtain his prescription for the controlled substance only from that physician

or physician's assistant

and fill or refill the prescription at only one specified pharmacy

;

(3)

Discuss the risks and benefits of using the controlled substance with the patient

, with the legal guardian or surrogate of the patient or with any other person at the patient's request;

(4)

After discussing the risks and benefits

pursuant to subparagraph (3),

receive

written

consent

from the patient or the legal guardian or surrogate of the patient to use the controlled substance;

(5)

If the patient is a high risk for substance abuse, enter into an agreement with the patient

pursuant to NAC 630.195; and

(6)

Document the requirements of subparagraphs (1) to (5),

inclusive,

in

medical records of the patient

that comply with the requirements of NAC 630.197.Slide7

(b) After prescribing the controlled substance:

(1) Review the progress of the patient towards the goals outlined in the

plan for treatment

and any new information about the etiology of the pain at periodic intervals based on the individual circumstances of the patient;

(2)

Refer the patient, as necessary, for additional evaluation and treatment to achieve the objectives of the plan for treatment

;

(3)

Monitor the patient's compliance

with instructions relating to use of the controlled substance and the plan for treatment;

(4)

Adjust the medication therapy, as necessary, to meet the individual needs of the patient

;

(5)

Discontinue treatment if

the physician or physician's assistant determines that the treatment is

not effective

; and

(6)

Maintain medical records for the patient that comply with the requirements of NAC 630.197.Slide8

More Recent Originsof Pressure on Providers to use CS for pain Fifth Vital Sign = Pain Patient Satisfaction required for reimbursement Unhappy patients in ER because not received sufficient opiates ER Physicians Pressured to Prescribe Opiates to increase patient satisfaction ratings

And Primary Care Physicians similarly affectedSlide9

Since 2011, how is Nevada doing in addressing the “opioid crisis” compared to the US as a whole?Nevada is doing better than the U.S. as a whole and substantially better than many areas in the U.S. (Maine, West Virginia, western Pennsylvania)Moreover, Nevada prescribers show continued progressive improvement in number and dosage of CS opioid prescriptions since 2011Slide10

U.S. DataSlide11

US DHHS/ CDC July 7, 2017Slide12

US DHHS/ CDC July 7, 2017Slide13

2012 National Prescription Audit – before PMPsSlide14

CDC Data, 2011-2016: U.S. up; Nevada downSlide15

Nevada Counties compared with others 2016Slide16

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US DHHS/ CDC July 7, 2017Slide18

NevadaSlide19
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MISUSEandAbusein

NevadaSlide21
Slide22

Patterns of Drug Diversion

Diversion Program Manager Michael Lewis

Michael.J.Lewis

@usdoj.gov

213-621-6711

May 2012Slide23

Drugs of Concern – Clark County 2012

OxyContin

®

(Schedule II)

Fentanyl (Schedule II)

Methadone (Schedule II)

Hydrocodone (Schedule III)

Cough Syrup (Schedule V)

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OxyContin® (Schedule II) (Mike Lewis 2012)Controlled release formulation of Schedule II OxycodoneStreet Slang: “Hillbilly Heroin” , “OC”, “Oxy”Strengths*: 10, 15, 20, 30, 40, 60, 80mgEffectsSimilar to morphine in effects and potential for

abuse/dependence

Street prices: $25 to $80 per 80mg tablet

Addiction, crime and fatal overdoses have all

been reported as a result of OxyContin

®

abuse*

The controlled release method of delivery (12 hours) allows for a long duration of drug action so it contains much larger doses of Oxycodone – abusers crush tablets for a powerful morphine-like high

OLD

*New OP formula developed to prevent the medication from being tampered. However, several unconfirmed ways to defeat have been listed on internet.

24

NEWSlide25

Fentanyl (Schedule II) (Mike Lewis 2012)Fentanyl is 100x more potent than morphineTrade-Names:Actiq®: dispensed in a berry flavored lollipop-type unitDuragesic®: trans-dermal patch for chronic pain

Fentora

TM

: effervescent tablet formulation

Approved by the FDA September 2006

Compared to same dose as

Actiq

®

, the effervescent tablet allows a larger amount of Fentanyl to be absorbed rapidly through the oral membranes

Street prices

:

$25 to $40 per patch

/lollipop

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Methods of Diversion (Mike Lewis 2012)Customers/ Drug SeekersDrug ringsDoctor-shoppingForged / fraudulent /alteredprescriptionsThe medicine cabinet

Employee pilferage

Hospitals

Practitioners’ offices

Nursing homes

Pain Clinics

The Internet

Practitioners/Pharmacists

Illegal distribution

Self abuse

Trading drugs for sex

Retail pharmacies

Manufacturing / distribution

facilities

Pharmacy/Other Theft

Armed robbery

Burglary (Night Break-ins)

In Transit Loss (Hijacking)

Smurfing

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Prescription Fraud (Mike Lewis 2012)Fake prescriptionsHighly organizedUse real physician name and DEA Registrant Number Contact Information false or “fake office”

Organizations set-up actual offices with contact information and staff (change locations often to avoid detection)

Prescription printing services utilized

Not required to ask questions or verify information printed

Use of out of state internet based printing services

Licensing of printing services in some states to reduce fraud

Stolen prescriptions

Forged

“

Smurfed

” to large number of different pharmacies

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Emerging Trends (Mike Lewis 2012)Counterfeit pharmaceuticalsOften obtained through internet sources, both domestic and foreignInternet sources advertise on Business-to-Business (B2B) sites, such a Alibaba.com, Tradeboss.com, etc.Substances usually obtained through foreign wholesalers

Substances contain wide variety of ingredients, some toxic, or active ingredients in insufficient levels

“

DEA has no legal authority over counterfeit pharmaceuticals

; however, assists agencies, upon requests.

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Internet sources of Controlled SubstancesSlide30

Internet sources of Controlled Substances30Slide31

Diversion of Legal Prescription Of those at highest risk for overdose, using prescription; 27% get their opioids using their own prescriptions 26% get them from friends or relatives for free23% buy them from friends of relatives 15% buy them from a drug dealerAbuse of legal prescriptions, and diversion of legal prescriptions is a

problem

Source: Nevada DHHS, 2016

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A Legal source of Controlled Substances(source: Nevada Patients)Mexico – border towns Some Pharmacies sell without a prescription Some Pharmacies will require a prescription from a Mexican physician Pharmacist will recommend a nearby physician The physician charges a fee for the prescription

The pharmacist fills the prescription

The price charged the American “gringo” is greater than for a Mexican national, but less than street prices in the U.S.

The U.S. citizen crosses the border with a legal medication obtained from “medical care” rendered in MexicoSlide34

LV Review Journal article February 20182016 – 550 drug deaths involved opioid use2017 – 210

drug deaths had at least one opioid as a cause of death

This was characterized as a “slight decrease” in the number of opioid-related deaths

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Legislative Enactments SB 288 (2015) PMP registration and mandatory checking every 6 months for profileSB 459 (2015) 7 days acute pain

Chronic pain

AB 474 (2017)

All specialties required

All Controlled Substances, II thru IV (V)

Multiple new mandates, unique investigation process, different requirements/discipline depending on professionSlide36

TOLERANCE,DEPENDENCE, ADDICTION and

TREATMENTSlide37

Anaphylaxis versus Opioid Overdose DeathsApproximately 2500 people died in USA 1999-2010 Anaphylaxis How many have written or recommended “Epipen” for patients?More than 64,000 drug overdose deaths in 2016 in the USA. National Institute on Drug Abuse, drugabuse.gov More than 300 people died in Nevada in 2015 from drug overdose with opioids as a cause of death. How many have written or recommended Naloxone (Narcan

)?

Seems prudent to prescribe or recommend Naloxone (

Narcan

) more.Slide38

Acute Pain: broken leg, kidney stone….7 days or 14 days or ?Refills or revisits Follow up from ER in timely manner with schedules fullWorse 3 days later with “dry socket”Preferred drug: nausea, and woozy with Lortab, stomach ache with ibuprofen, but can tolerate “Percocet” does requesting a specific controlled substance (CS) for pain indicate a “drug abuser”? if ER doc prescribes a CS and patient seen 3 days later by HC provider, is prescribing more of same medication by HC provider prohibited for “ongoing treatment”?

probably not, since not being treated by ER doc for ongoing problemSlide39

Chronic PainStable on same dose of narcotic or benzodiazepine for years even decades. Functional Options for Patients? Is prescriber at risk for continuing same medication? On-call physician refills of same medication prohibited? See AB 474, Sec. 60(1)(b) and newly amended NRS 639.23507(1)(b)Slide40

TOLERANCENeed more for same effectLess effect for same doseOccurs for effects and side effects: euphoria, sedation, respiratory depression, vomiting, analgesiaDoes not occur for side effects of constipation, miosis, sweating Gradual increasing dose creates high tolerance for otherwise lethal doses.Withdrawal: gets when stops or reduces the opioidOne last same-dose-fix is just that, for person who celebrates sobriety Slide41

Physical DEPENDENCE (not addiction)Physiologic change or adaptation in an organism in response to repeated administration of a drugOpioid Use Disorder is a disease with above criteria for pathologic use or addiction.Slide42

ADDICTION, aka substance use disorderPer SIRI: the fact or condition of being addicted to a particular substance, thing or activity. NIH: …a chronic, relapsing brain disease that is characterized by compulsive drug seeking and use, despite harmful consequences.Wikipedia: State characterized by compulsive engagement in rewarding stimuli despite adverse consequencesASAM (2001): A primary, chronic, neurobiological disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations….impaired control…compulsive use…despite harm…and craving.Slide43

Overdose with Respiratory DepressionUnusual to be just opioidCommonly associated with alcoholAggravated by co-administration of a benzodiazepineSadly may occur in a rehabbed person who does “one last fix” at same-dose-as-used-to-use but tolerance has disappeared.New illicit pills or heroin now laced with fentanyl without labellingRespiratory depression lasts longer than pain relief for those using methadone.Slide44

Substance Use Disorder: Stigma less using:Opioid, OUDAlcohol, AUDTobacco, TUDSlide45

DSM-5 criteria for Substance Use Disorders1) use in larger amounts or longer periods than intended2) Unsuccessful efforts to cut down3) Excessive time spent taking drugs4) Failure to fulfill major obligations5) Continued use despite knowledge of problems6) Important activities given up7) Recurrent use in physically hazardous situations8) Continued use despite social or interpersonal problemsSlide46

DSM-5 changes: physiologic criteria & severity9) Tolerance10) Withdrawal11) CravingSeverity: 0-1 criteria: no diagnosis2-3: mild4-5: moderate6 or more: severeSlide47

TREATMENTThe Waiver from the Harrison’s Act 1914No narcotic can be used to treat a narcotic addiction without waiver“X” in front of DEA number instead of first initial.Those with waiver - two DEA numbersDrug Abuse Disorder Act (DATA 2000) created the waiver for the buprenorphine and Suboxone (buprenorphine and naloxone) to be used for addiction treatmentSlide48

Methadone: for pain or for addictionMethadone can be prescribed for treatment of addiction only thru opioid treatment centers by special licensees.Long acting pain medication but respiratory depression effect longer than pain relieving qualities.Patient must go to the center for the treatment, no script to take home.*higher risk of prolongation of the QTc interval assoc w/ TdPSchedule IISlide49

Buprenorphine Schedule II Partial agonist Advantages for Acute PainTwelve reasons for considering buprenorphine as a frontline analgesic in the management of pain. J Support Oncol. 2012 Dec; 1096):209-19Works for cancer pain, neuropathic pain, less constipation, ceiling effect on respiratory depression, less cognitive impairment, not immunosuppressive like morphine or fentanyl, does not cause hypogonadism, no QT prolongation*, effective in elderly, safe in renal failure and for those on dialysis, and withdrawal is milder with lower abuse liability than full agonists.Slide50

Opioid Dependency: Suboxone, Zubsolv, Bunavail all Schedule IIIBuprenorphine/naloxone - all sublingual tab or buccal filmDesigned to prevent diversion/IV useNaloxone poorly orally absorbedNaloxone inclusion prevents melting down abuseBuprenorphine monotherapy recommended for long-acting opioid inductionSlide51

Naloxone opioid antagonistUse in suspected overdose; will cause acute withdrawal if on opioid.Not a controlled substance per Controlled Substance ActAvailable with or without a prescriptionGeneric (IM) is about $40; Narcan (nasal spray) about $130Insurance will only pay if prescribed for the person needing itMust take patient to the hospital after use because it wears off and the respiratory depression resumes

Other substances may be involved which are not amenable to naloxone, so ER hospital evaluation is prudentSlide52

Naltrexone: ReVia, Vivitrol, DepadeIM: 380 mg q 4 weeks option for maintenance of abstinence opioids and ETOH. Caveat- only after negative naloxone challenge – ie., no withdrawalPO: 50 mg daily to treat AUD - maintenance of abstinenceEmbeda: morphine/naltrexone - chronic severe pain

Troxyca

ER: morphine/naltrexone - chronic severe pain

Contrave

: bupropion/naltrexone: for Obesity as an adjunct to diet and exerciseSlide53

People fail 50% to 90% of timeDo not discharge the patientWork with the patient like any other chronic diseaseConfidentiality of the treatment even from subpoena See new federal regulations: 42 CFR part 2 providing even greater privacy protectionsUse MAT (medication assisted treatment) for however long it is needed Slide54
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BTW: Schedule V drugs mandate PMP inquiry before prescribingExamples of Schedule V controlled substances:Low dose codeine common in cough medicationsLomotilLyricaPhenergan with codeineVimpat: lacosamide for anticonvulsantSlide56

Not ScheduledRozerem: melatonin agonist for sleepTessalon: for coughAntidepressantsAntiepilepticsAntihistaminesAcetaminophenNSAIDsEarplugs and eye masksIce cubes and moist heatSlide57

New Regulations and pending regulatory actions Board of Pharmacy 2015 Naloxone available by Rx to family or friend 2017 over the counter Naloxone Board of Medical Examiners Subcommittee on R100-17P recommends to NBME Board to rescind R100-17P

New proposed 2 hour CME requirements for

dispensing

licensees only

Board of Osteopathic Medicine, Nursing Board, Podiatry Board

Regulations mandating 2 hour training/CMEs only; no additional punitive actions

Dental Board indicated intent to mandate 2 hour training/CMEs without new additional punitive actions

Optometric Board has not yet promulgated regulations re AB 474Slide58

Do SomethingGet DATA 2000 waiver: 4 hrs live with 4 hours online OR 8 hours online Offer MAT with buprenorphine or Suboxone in your practiceGet naloxone for office IM or for Nasal spray, and show peopleWrite naloxone for every opioid patient (insurance coverage)Limit acute pain opioid scripts to 7 daysRefer to pain doctor or other type provider for another opinion if patient not responding as expected, or if you suspect diversion

Lobby patients to fix the flaws in AB474 in the next legislative session

Be an early adopter of a “change in the culture of medicine” which has heretofore avoided involvement in Legislative matters

The reason to be involved is not for what YOUR legislator can do FOR you, but what your legislator can do TO you – with AB 474, you have been

TO’dSlide59

Fix the Bill next session and proposals now for contemplations of interim salutatory regulations:Focus on chronic pain; drop the mandates for short term acute and post-op pain (see the Guidelines of the Federation of State Medical Boards)Facilitate partner coverage same CS prescription, and covering physician same CS prescription, after checking with PMPFacility seamless transfers of patients from one provider to another minimizing repetitive paperwork or processesHospice, palliative care, end of life care, cancer pain – all should be carve-outs as recommended by Federation of Medical Boards Model Guidelines for the Chronic Use of Opioids for Pain Treatment; add exceptions to the law for individual emergencies and public health emergencies

Encourage clinical judgement an individual patients and provide physician protection for such

Informed consent may be provided orally, and not necessary for subsequent physicians using same class of controlled substances

All Boards treating prescribers the same as to mandates and discipline for the use of controlled substances in treating pain

Board of Pharmacy to promulgate regulations for the use of controlled substances for the treatment of chronic pain – in consultations with all affected Boards with discussions and testimony taken by practitioners and the public in open sessions conveniently scheduled to facilitate input; no secret sessions to develop laws – convenient, transparent, recorded Board meetings and regulations development sessions

Peer review involvement and protections for both the reviewer and the practitioner being reviewed

All Board member involvement in all stages of regulations development and approval

OPT and MAT are longer than 365 days on same medication; reasons for greater than 365 days of medication in 365 days to be noted in patient’s medical records

Use “Due Process” for inquiry, investigation, formal complaint, and disposition already in place; remove Executive Director or designee’s special authority; make Board members responsible for equitable due process

Require all health care professions Boards to meet publicly at least every other month; sessions available on the internet and recorded for later public viewing; allow at least 5 minutes for testimony in “public comment” periods of meetings

Encourage prescriber education on MAT, OPT, OMM, PT, CBT, SBIRT, and CBT; and use of Naltrexone for treatment of alcoholism and opioid addiction

Dispensing physicians only ones of MDs required to do CME, include all prescribers

Avoid “double jeopardy” with mandated attestation of compliance with all CS pain treatment statutes and regulations

Define specifically the meaning of “initial prescription” in Section 51 of AB 474

Consider the effect of “summary suspensions” (prescription of controlled substances or ability to practice) on

patients

of the practitioner

Licensing Boards to have substantial office presence in southern as well as northern Nevada providing full preliminary inquiry of complaints, full investigations, informal and formal hearings provided on site; Boards unable to do so to be combined so that such capability can be provided for the public as well as to licensees

Boards to act promptly on complaints with protection of the public as the primary concernSlide60

Options for Practitioners under AB 474Continue to prescribe. Adapt to new rules and regulations Prescribe controlled substances only for NOT FOR PAIN purposes, complying with those mandates in AB 474 (no prescriptions for CS for the treatment of pain)Continue prescribing CS for treatment of pain in patients for whom you initiated the CS treatment of pain prior to Jan 1, 2018, but do not initiate the prescription of CS to treat pain for any new patients (until AB 474 is “fixed”)Quit prescribing controlled substances for any purpose – new or established patients; do not renew your Board of Pharmacy Controlled Substances Certificate (keep your DEA active in hopes of AB 474 “fixing”)

Refuse to supervise residents or PAs due to the added liability under vicarious liability and

respondeat

superior

legal

principles

Move to another State with less onerous rules on the prescription of controlled substances (consider nearby Utah and Arizona; and Idaho, Montana, and even California)

Do not come to NevadaSlide61