The Closed System of Controlled Substances

DOJ->FBI->DEA

rehab programs

pharmacy practice

import/export controlled substances

...

•Serves as enforcement for federal drug laws

•Works closely with both state and local authorities

•Prevent diversion

•Ensuring a supply for legitimate practices/needs

Attorney General

•Have a high potential for abuse

•Have no currently accepted medical use in treatment in the U.S.

•Lack accepted info on the safety of their use, even under medical supervision

Schedule 1

Schedule 1

Schedule 1

Schedule 1

•Pain and illness in terminal ill

•Cancer patients

synthetic THC

-can help with pain and illness in terminal ill

-cancer patients

Terminal ill man in California with 8 marijuana plants

Sheriffs raided house and took no action

DEA later destroyed the plants

Who is right?

•Substances in this schedule have a high potential for abuse which may lead to severe psychological or physical dependence

Ritalin

Percocet

Dilaudid

Demerol

Dolophine

Adderall, Dexedrine

Vicodin

Sublimaze or Duragesic

Oxycontin

schedule 2

schedule 2

schedule 2

schedule 2

schedule 2

schedule 2

schedule 2

schedule 2

schedule 2

schedule 2

Substances in this schedule have a potential for abuse less than substances in schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence.

•Substances in this schedule have a low potential for abuse relative to substances in schedule III

schedule 3

schedule 3

(Suboxone® and Subutex®)

schedule 3

Xanax

Versed

Ativan

Restoril

Klonopin

Valium

schedule 4

schedule 4

schedule 4

schedule 4

schedule 4

schedule 4

•Substances in this schedule have a low potential for abuse relative to substances listed in schedule

-must be identified with a C

-C-1, C-2

for antitussive, antidiarrheal, and analgesic purposes

schedule 5

schedule 5

containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams

•All pharmacies that dispense controlled substances obtain a state license

•Must register with DEA

•Use form 224

form 224

3 years

DEA Form 224a

The seller, however, must SELF-CERTIFY with DEA

every year

18 years old

• Enacted to regulate the OTC sales of pseudoephedrine, ephedrine, phenylpropanolamine

ephedrine,

pseudoephedrine,

phenylpropanolamine

T

T

T

•Employee training

•Placement out of customer reach

•Customer id

•Logbooks

•Purchase limits

3.6 grams of these products to each customer, regardless of the number of transactions

9 grams per customer each month

7.5 grams per customer/month

•Prescribing Limits

•Expands the current Prescription Drug Monitoring Program (PDMP)

•Pain Management Clinic regulation changes

•"normal, predicted, physiological, and time-limited response to an adverse chemical, thermal, or mechanical stimulus associated with surgery, trauma, or acute illness "`

•Cancer

•A terminal condition

•Pain treated with palliative care

•A traumatic injury with an Injury Severity Score of 9 or higher

non-acute pain

non acute pain

non acute pain

non acute pain

acute pain

7 day limit

!!

-nonacute conditions

-chronic pain

Can be prescribed an emergency opioid Indicate "nonacute pain"

Pain Management Clinics

•January 1, 2019

•All need to be registered with DOH OR

•Certificate of exemption

•Required consultation

PDMP

4 years

kept in a separate file

are kept together in a separate file or with non-controlled prescriptions

Form 106

WITHIN 1 business day

1.Stored in locked container

2.Dispersed throughout the pharmacy

3.Combination of the two

F

•Must maintain an exact count inventory

•Typically keep a paper inventory log in addition to computer inventory system

•Updated after EVERY fill

C2s

C2s

C2s

•Estimated count

•If container holds more than 1000 units, will require exact count

•Typically done in computer inventory system

C3-C5

C3-C5

C3-C5

C3-C5

•Appoint a Compliance Officer

•Conduct An Annual Audit Of CSA Requirements

•Annually Review Record-keeping

•Review Security

•Perform Periodic Controlled Substance Audits

on a DEA 222 form

supplier retains copy

supplier sends to DEA office

registrant retains copy

•DISTRIBUTION

•PURCHASE

•TRANSFER

call supplier first

Controlled Substance Ordering System (electronic Form 222)

•Uses Public Key Infrastructure (PKI) technology

•Needs a digital certificate

•Doctor of Medicine (MD)

•Doctor of Osteopathic Medicine (DO)

•Advanced Registered Nurse Practitioners and Physician Assistants

•Podiatrist

•Dentist

•Optometrist

Only 7 day supply for CII as of 1/1/17

Only acetaminophen with codeine #3

•These registrations must be renewed every 3 years

•Limited by scope of practice

•What is the catch?

•Scope of practice

Assigned to clinicians by the Drug Enforcement Administration
Allow prescription of controlled substances

•2 letters followed by 7 numbers

•First letter identifies the type of registrant

•Second letter is first letter of last name

•The last number of the sum of odd numbers + (sum of even number) * 2 should equal the last number

physicians, dentists, veterinarians

Midlevel practitioner (e.g., Physician Assistant)

Some military personnel are authorized to prescribe controlled substances

F

Military Service Number

•Practitioners who are agents/employees of a health care system may use the hospital/institution DEA number

•MD signature and date

•Patient's full name and address

•Practitioners full name and address

•Practitioners DEA #

•Drug name

•Strength

•Dosage form

•Quantity prescribed

•Directions for use

•Number of refills authorized (if allowed)

Schedule II,

Schedule III,

or Schedule IV drugs

•background color must be blue or green and resist reproduction

•blank must be printed on watermarked paper

•blank must resist erasures and alterations

•"void" or "illegal" must appear on any copy

•Preprinted name

•Address

•Type of practitioner

•Space for the prescriber's DEA number

•Software must meet specific DEA requirements

•Must be DEA-registered pharmacies

•May add or change patient's address upon verification

•May add or change dosage form, drug strength, quantity, directions for use, or issue date:

•Only after consultation with and agreement of the prescribing practitioner

•Such changes are noted on the prescription and medical records

•In compliance with state/local laws, regulations, or policies

•May never change the patient's name

•May never change the controlled substance prescribed

May never change the prescriber's signature

•Each prescription must be issued on a separate prescription blank

No refills or transfers

Must be for a legitimate medical purpose by a practitioner acting in the normal course of professional practice

•Prescriber can provide patients multiple prescriptions

•Must be dated the date issued

•Must include instructions on each prescription indicating the earliest date that can be filled

•90 day limit

•Prescriber may transmit a Schedule II to the pharmacy

•Original prescription must be presented to pharmacist at time of dispensing

•Pharmacist must keep the original prescription with oral prescription

A prescription for a COMPOUNDED controlled substance for DIRECT ADMINISTRATION to the patient

Residents of LONG TERM CARE FACILITY (LTCF)

HOSPICE PATIENT

•Maximum 5 times

•After 5 refills or 6 months (whichever comes first) requires a new prescription

•Dispensing initials

•Date prescription was refilled

•Amount on the refill

•If pharmacist only initials, indicates a full amount

only one time

maximum refills permitted by law and prescriber's authorization

licensed pharmacists/pharmacist interns

•Write VOID on the face of invalidated prescription (electronic—add to record)

•On the invalidate prescription (or on the electronic record) must include

•Name of pharmacy transferred to

•Name of address transferred to

•DEA number of pharmacy receiving prescription

•Date of transfer

•Name of pharmacist/intern accepting transfer

•Date of issuance of original prescription

•Original number of refills authorized on original prescription

•Date of original dispensing

•Number of valid refills remaining and date(s) and location of previous refills

•Pharmacy name, address, DEA registration number, and prescription number from which the prescription was transferred

•Name of pharmacist who transferred the prescription

•Pharmacy name, address, DEA registration number, and prescription number from which the prescription was originally filled

•No federal limits on refill,

Florida has 6-month expiration

•Can only transfer one time

T

CAUTION: Federal law PROHIBITS the transfer of this drug to any person other than the patient for whom it was prescribed

240 cc (8 ounces)

120 cc (4 ounces)

48 dosage units

24 dosage units

all within 48 hours

•Wholesale distributor must take reasonable measures to

•identify its customers

•understand the normal and expected transactions conducted by those customers

•identify those transactions that are suspicious in nature

2 years

• Review the patient record

•Over-utilization or under-utilization

•Therapeutic duplication

•Drug-disease contraindications

•Drug-drug interactions

•Incorrect drug dosage or duration of drug treatment

•Drug-allergy interactions•Clinical abuse/misuse

a physician must register themselves if they prescribe for:

•Patients for chronic nonmalignant pain

•Pain unrelated to cancer which persists beyond the usual course of disease or the injury

•Pain more than 90 days post surgical

•Otherwise not required for prescribing controls for other purposes

...

•Opioids

•Barbiturates

•Benzodiazepines

•Stimulants

So commonly abused because of their availability

Known as E-FORCSE® (Electronic-Florida Online Reporting of Controlled Substance Evaluation Program)

a doctor's office, clinic, or health care facility that routinely conspires in the prescribing and dispensing of controlled substances outside the scope of the prevailing standards of medical practice in the community or violates the laws of the state regarding the prescribing or dispensing of controlled prescription drugs.

•No physical exam was given or required

•Only accept cash as a payment method

•Meeting with multiple patients in the parking lot

•Excessive traffic coming in and out of the doctor's office

Laws and regulations have changed there are now less than 400 pain management clinics registered in Florida

It lists the top oxycodone dispensing physicians

!!!!!!!

RESOLVE RED FLAGS

VERIFY THE PRESCRIPTION

CLARIFY WITH THE PHYSICIAN AND/OR PATIENT

DOCUMENT RESOLUTION OF ANY RED FLAGS

than the next business day

close of the next business day

a first degree misdemeanor

DEA 222 form

DEA 41 form

Pharmacy must document:

-drug name

-dosage form

-strength

-quantity

-date transferred

DEA 106 form

•Must be able to retrieve original prescription information for prescriptions authorized for refill

Must be able to retrieve current refill history for schedules III-IV

•System must have a printout each day with the refills for the day—pharmacists must verify accuracy by signing and dating printout

A.Name of Pharmacy/Address

B.Date

C.Number of packages, size, desired strength

D.Total number of lines used

E.Signature -authorized person or power of attorney

A.Name of Pharmacy/Address

B.Date

C.Number of packages, size, desired strength

D.Total number of lines used

E.Signature -authorized person or power of attorney

•Single copy DEA 222 Form

•Purchaser fills out form and makes a copy (paper or electronic)

•2-year transition period in which either the triplicate or single form can be used until October 30, 2021

ARCOS system

Include serial numbers of each lost or stolen form

Include the approximate date of issuance (if unsure of numbers)

if found also report to DEA

•Pharmacy must keep a receipt (invoice or packing slip)

•Finished form of the controlled substance

•Name of each controlled substance

•Number of containers ordered and received

•a written and a numerical notation of the quantity of the controlled substance prescribed

•a notation of the date in numerical, month/day/year format, or with the abbreviated month written out, or the month written out in whole

•Must have the prescription from the practitioner within 7 days with "Authorization for Emergency Dispensing" either in person or mail (postmarked by 7 days)

•The pharmacists must attach the original to the oral emergency prescription

•If the prescriber does not send, the pharmacist must notify the DEA Diversion Field office

•Must have the prescription from the practitioner within 7 days with "Authorization for Emergency Dispensing" either in person or mail (postmarked by 7 days)

•The pharmacists must attach the original to the oral emergency prescription

•If the prescriber does not send, the pharmacist must notify the DEA Diversion Field office

•Prescription for a Schedule II can be partially filled

•Must dispense the remaining portion within 72 hours

•If not able to dispense within 72 hours, need a new prescription

•If not able to dispense within 72 hours, must let the prescriber know

72 hours

need a new prescription

May fill prescription in partial quantities to include individual dosage units

valid for a period not to exceed 60 days

•Date of the partial filling

•Quantity dispensed

•Remaining quantity authorized

•Identification of the pharmacist

Must note on the prescription—"terminally ill" OR "LTCF patient"

•Name and address of purchaser

•Name and quantity of the controlled substance purchased

•Date of each purchase

•Name or initial of the pharmacist who dispensed the substance

•Patients for chronic nonmalignant pain

•Pain unrelated to cancer which persists beyond the usual course of disease or the injury

•Pain more than 90 days post surgical

•Otherwise not required for prescribing controls for other purposes

•Disciplinary action include making misleading, deceptive, or fraudulent representations in or related to the practice of the licensee's profession

•Pharmacists cannot deceive the patient