bureau of drug control - charleston, sc health/health... · roles of the bdc. roles of the bdc •...

Bureau of Drug ControlSarah ChapmanPharmD, LEO

Presentation Objectives

• Role of DHEC Bureau of Drug Control• Opioid Crisis Facts & Statistics• Requirements of a Valid Controlled Substance Prescription• Regulation Update • Proper Controlled Substance Accountability & Documentation

DHEC is a regulatory agencyThe Bureau of Drug Control regulates the dispensing and administration of controlled substances.This is done through:1. Inspections2. Audits 3. Investigations4. Educational Programs

Bureau of Drug Control Inspectors

• SC licensed pharmacists • Minimum of one year of working experience in

pharmacy practice• Complete SC Criminal Justice Academy training and

become a class I law enforcement officer

• Enforces the South Carolina Controlled Substance Act

• Manages SCRIPTS (South Carolina Reporting & Identification Prescription Tracking System)

• Conducts annual site inspections of pharmacies, hospitals, practitioners, EMS Units, researchers, and K9 Units

• Address violations • Respond to complaints

Roles of the BDC

Roles of the BDC• Site Inspections

• BDC typically conducts 750-850 inspections annually

• Audits• Conducts 75-100 in-depth, onsite

accountability audits of controlled substances stocked

Roles of the BDC• Address Violations

• Violations and discrepancies discovered during investigations, inspections, or audits may lead the BDC to take administrative action against a facility or practitioner

Roles of the BDC• 750 to 1,000 complaints each year involving

diversion of controlled substances from legal outlets• Approximately 50% result in arrest and

prosecution in state or federal court• Approximately 35% of those prosecuted

are health care professionals

Controlled Substance Trends

The Opioid Epidemic• According to the CDC,

opioids (including prescription opioids and heroin ) killed more than 33,000 people in 2015

• Nearly half of all opioid overdose deaths involve a prescription opioid.

Commonly Abused Prescription

Controlled Substances

National Drug Control Policy and Prescription Drug Abuse: Facts and Fallacies –Laxmaiah Manchikanti, M.D., 2007

The population of the United States comprises 5% of the world’s population.“Parallel to opioid supply and nonmedical prescription drug use, the epidemic of medical drug use is also escalating with Americans using 80% of world’s supply of all opioids and 99% of Hydrocodone.”

Top Rx Drugs of Abuse• Hydrocodone (CII) #1 Dispensed 2015 – Present*

• Vicodin®, Norco®, Zohydro®….• Street names: Vikes, Hykes….

• Capsule, Liquid, Tablet• Swallowed, Snorted, or Injected• “Cocktail” also known as the “Trinity” used by drug

abusers:• Hydrocodone/Carisporodol/Alprazolam

* Based on 2018 SC PMP Data: 89,742,41

Top Rx Drugs of Abuse• Tramadol (CIV) #2 Dispensed 2018

• Ultram®, ConZip®, Ultracet®….• Street names: Trammies, Chill Pills, Ultras ….

• Tablet, Capsule, ER• Swallowed, Snorted, or Injected• Veterinary Patients

Top Rx Drugs of Abuse• Alprazolam (CIV) #3 Dispensed 2018

• Xanax®

• Street names: Xannys, Bars (2mg), Candy, Tranks…. • Often prefer alprazolam due to rapid onset and

longer duration of action

Top Rx Drugs of Abuse• Oxycodone +/- APAP (CII) #4 and #8

Dispensed 2018• Percocet®, Roxicodone®, OxyContin® …• Street names: Oxy, Percs….

• Capsule, Liquid, Tablet• Swallowed, Snorted, or Injected

Top Rx Drugs of Abuse• Codeine (CII, III, V)

• Various brand names• Street names: Lean, Purple Drank, Cody

• Tablet, Capsules, and Liquid Forms• Injected or swallowed (mixed with soda)

What is necessary for a controlled substance prescription to be valid?

Requirements of a Valid Controlled Substance Prescription

(1) Valid practitioner-patient relationship(2) Treatment of a legitimate medical condition(3) Practitioner acting in the usual course of

professional practice(4) Properly licensed and registered practitioner-

LLR license, prescriptive authority, DHEC and DEA controlled substance registrations (register for each class of controls individually)

Controlled Substance Prescriptions

SC 44-53-360. Prescriptions(c) No controlled substances included in any schedule may be distributed or dispensed for other than a medical purpose. … No practitioner may dispense a controlled substance outside of a bona fide practitioner-patient relationship [1103, 1204].

Valid controlled substance prescriptions (cont.)

SC 44-53-360. Prescriptions

(h) A prescription, in order to be effective in legalizing the possession of a controlled substance and eliminating the need for registration of the recipient, must be issued forlegitimate medical purposes. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner...

Usual Course of Professional Practice

Reg. 61-4 Section 1002(a) A prescription for a controlled substance to be effective shall be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his or her professional practice.

Usual Course of PracticeReg. 61-4 Section 1002(c) A prescription may not be issued for the dispensing of narcotic drugs listed in any schedule to a narcotic drug dependent person for the purpose of continuing his or her dependence upon such drugs…

New Regulations

H.4487: Eliminates registration renewal grace periods (44-53-280)

• All registrations to manufacture, distribute, or dispense controlled substances.

• Any practitioners that missed the October 1st

deadline must submit a new application.• New application fee plus a late penalty ($225

total)• Processing time 12-15 days

H.4487: Continued

• To reinstate or submit a new application DHEC form 1174A must be completed.

• Available online• Renew annually• Mailed 45 daysprior to expiration

H.3826: Tamper – Resistant Prescription Pad (44-53-360)• Effective July 16, 2018• Requires written prescriptions for controlled

substances to be written on tamper-resistant prescription pads.

• Prescriptions transmitted by facsimile, orally, or electronically are exempt from the tamper-resistant prescription pad requirements.

• Must meet at least one of the Center for Medicare and Medicaid Services (CMS) requirements to be compliant.

H.3826: Continued • Guidance: National Council for Prescription

Drug Programs (NCPDP) is available online https://scdhec.gov/health-regulation/drug-control-register-verify

H.3826: Continued

NCPDP 2008 Guidelines

S.918: Limitations for initial opioid prescriptions (44-53-360)• Initial opioid prescriptions for acute pain

management or postoperative pain management must not exceed a seven-day supply

• Exceptions: Cancer pain, chronic pain, hospice care, palliative care, major trauma, major surgery, treatment of sickle cell disease, treatment of neonatal abstinence syndrome, or medication-assisted treatment for substance use disorder.

S.918 Continued – Pharmacy Level

• Pharmacies may choose to implement their own verification procedures for prescriptions in accordance with the requirements of S.C. Pharmacy Practice Act.

• Pharmacists continue to have the authority under state law to refuse to fill a prescription if they are concerned about the “legitimate” nature of the prescription.

S.918 Continued- PMP

• Effective November 15, 2018• Requires DHEC to develop and maintain as part

of the Prescription Monitoring Program (PMP) a system to provide prescription report cards to practitioners

• Inform the practitioner about certain prescribing trends

H.3824: Reviewing PMP (44-53-1645) • Effective May 19, 2017

• practitioner, or the practitioner’s authorized delegate, shall review a patient’s controlled substance prescription history, as maintained in the PMP, before the practitioner issues a prescription for a Schedule II controlled substance.

H.3824: Does NOT Apply• To Practitioner issuing a prescription for a Schedule II

controlled substance: - to treat a hospice-certified patient -prescription that does not exceed a five-day supply for a patient-for a patient with whom the practitioner has

established relationship for the treatment of a chronic condition; however, the practitioner must review the patient’s controlled substance history maintained in the PMP at least every three months

H.3824: Does NOT Apply Continued • Practitioner approving the administration of Schedule II controlled

substance by a health care provider licensed in South Carolina

• Practitioner prescribing Schedule II controlled substance for a patient in a skilled nursing facility, nursing home, community residential care facility, or an assisted living facility and the patient’s medications are stored, given, and monitored by staff

• Practitioner who is temporarily unable to access the prescription monitoring program due to exigent circumstances; however, the exigent circumstances and the potential adverse impact to the patient if the prescription is not issued timely must be documented in the patient’s medical record.

H.4117 Prescription Monitoring Program (44-53-1650)• Effective May 3, 2018• Authorizes DHEC Bureau of Drug Control to provide data in the

PMP to the presiding judge of a drug court pertaining to a specific case involving a designated person.

H.4488 Prescription Monitoring Program (44-53-1650)• Effective May 3, 2018• Authorizes DHEC’s Drug Control to provide data in the PMP to a

coroner, deputy coroner, medical examiner, or deputy medical examiner who is involved in a specific inquiry into the cause and manner of death of a designated person pursuant to Chapter 5, Title 17

S.345: Prescriptive Authority(40-33-34)• Effective July 1, 2018• Revises the prescriptive authority of certain advanced

practice registered nurses (APRN)/Nurse Practitioners (NP).

• Authorizes physician assistants to perform telemedicine to include authorized prescribing of Schedule II and Schedule III prescriptions.

S.345: Continued • Supervising physician must approve in practice agreement• Must update DHEC registration• Drug schedules listed on a current DHEC controlled substances registration

can be changed by submitting the Schedule Change Request form to: bdc@dhec.sc.gov.

What is drug diversion?…the diversion of licit drugs for illicit purposes

CMS Drug Diversion in the Medicaid Program: State Strategies for Reducing Prescription Drug Diversion in Medicaid January 2012

Medication Disposal• Prevention is more than prescribing less, it’s about

removing what’s in circulation• Most pharmacies cannot take drugs back once

dispensed• Drug Disposal Sites• DEA Drug Take Back Day twice a year• Activated charcoal products

-can work on pills, patches, liquids-for use at home-safe for landfills

Common Diversion Methods• Legally obtaining drugs for a medical condition and then selling or

transferring the drugs to others

• Stealing drugs from sick family members or befriending a patient who gets lots of C/S

• Befriending a patient who is prescribed lots of controlled substances

• Lying to physicians regarding pain level

• Calling physicians after-hours and claiming to be a patient of his/her partner

• Going to multiple practitioners and/or different pharmacies

• Altering prescriptions that were legally issued

Common Diversion Methods (cont’d.)• Using stolen prescription blanks

• Generating Rx blanks on computer or making photocopies

• Calling in their own prescriptions for controlled substances

• Diversions by employees (for personal use/profit) [Reg 61-4-410]

• Armed robberies and/or break-ins of pharmacies, drug wholesalers or physicians’ offices

Fraudulent Call in Prescription

• Ask direct questions about other health care providers that patient may be seeing and other medications patient is receiving; document responses.

• Written “sole-provider” contracts can be very useful in most settings.

• Use resources that are available.• Prescription Monitoring Program

Doctor Shopping

Prescription Forgery

• Commonly due to stolen or photocopied prescription blanks.

• Increase in scanned or computer-generated forgeries.

• Large number of fraudulent telephoned prescriptions for C-III and C-IV, especially alprazolam and codeine.

Altered Prescriptions

• Altered quantity• Altered refills• Altered dates• Altered medication strengths• Medications added to a prescription

Date changed from 5/12/2014

to 5/6/2014

Prescription Forgery

Entire Rx was written over in black sharpie

Prescription Forgery

Forty is misspelled

Prescription Forgery

Rx quantity changed from #16

to #60

Prescription Forgery

Added to Rx

Suggestions to prevent forgeries

• Use prescription blanks that are difficult to photocopy or scan.

• Always secure prescription pads/paper.• Do not leave prescription blanks in exam rooms.• Never sign blank prescriptions!

Suggestions to prevent prescription alteration

• Write out quantity in numerals and spell out alphabetically.

• Line or zero out refills if none authorized.• Line out unused portions of prescription or

write total number of rx on script.• Indicate the number of prescriptions authorized

Diversion of Controlled Substances by an Employee

• Do not say anything to the employee; obtain as much information as possible without causing any suspicion

• Contact your local law enforcement agency or SC DHEC Bureau of Drug Control

• Reg 61-4-406(a) - prohibits any registrant from employing a person with a felony record related to controlled substances to have access to controlled substances

Security Requirements• Controlled substances should be stored in a

securely locked and substantially constructed cabinet

• Limit access to the locked cabinet• Have a witness to all wastage and have both

persons sign• Registrants should report any theft and/or loss to

DHEC Bureau of Drug Control and complete DEA 106

When to Contact Drug Control• Suspicion of forged, altered, or fraudulent

controlled substance prescriptions• Deception or misrepresentation made by

patients to obtain controls• Suspected “doctor-shopping” activity

Comments and Questions