Controlled Substances Act

Valid CSA Prescriptions

To be dispensed to an ultimate user (patient)By an authorized prescriberIn the due course of professional practiceFor a legitimate medical purpose

Authorized Prescribers

Up to state who can prescribeMust register with DEA and stateDEA Number (eg, AJ0213455) First letter usually “A” or “B” for physicians;

“M” for mid-level practitioners Second letter usually first letter of last name

or a “9”. May be first letter of former last name.

Number portion has 6 digits plus “check digit”

WA Authorizes

MD or DO – all schedulesDMD, DDS – all schedulesDVM – all schedulesPodD, DPM – all schedulesAny of the above in any state in the US British Columbia physicians can prescribe

legend drugs, but not controlled substances unless have a US-issued DEA No.

Mid-level practitioners in WA

ARNPs Schedule V Schedule II-IV if have a joint practice agreement

May dispense up to a 72-hour supply

PAs – All schedules approved by supervising MDOptometrists – limited drug list, may include III, IV, V

No more than a 7-day supply of CSAs No more than 30 dosage units of III or IV Single doses of benzodiazepines for pre-procedure use Must put a “notation of purpose on all Rxs”

Pharmacists – any schedule within scope of authorizing prescriberOthers who are not physicians, dentists, or veterinarians (none authorized currently in WA)

Hospital or Institutional DEA Numbers

Any employee of hospital may use hospital DEA number with permission in the course of his or her duties if otherwise authorized to prescribeUnregistered VA employees, likewiseUse hospital DEA # plus internal code; must add stamped, printed, or typed name as well as signatureMay be filled at community pharmacies

Due Course of Practice

Bona fide patient-physician relationshipWithin scope of practice

Within scope of practice

Physician - entire human bodyDentist - head and neckPodiatrist - ankles and feetNurse practitioner - specialty areaPhysician assistant - same as supervising physician

Within scope of practice

Optometrist - eyesOphthalmologist - same as physicianPsychiatrist - same as physicianPsychologist - not generally allowed to prescribeVeterinarian - entire animal bodyPharmacist - humans, within scope of authorizing practitioner

Legitimate Medical Purpose

Not “for office use”Not fraudulent nor forgedNot to maintain addiction (outside of MMP)Must be within generally recognized practice standards for the given profession, with due consideration to the prescriber’s specialty

Legitimate Medical Purpose

Written for self or family?Outside of package insert indications?(Different issue with CSAs than legend drugs)

Specific exclusions anabolic steroids for weight training CSA stimulants (eg, Dexedrine) for

appetite control

Corresponding Responsibility of Pharmacist

“Knew or should have known”Medical vs non-medical usesCivic duty to prevent/report crime vs professional duty to treatRight to protect self from being forced to act illegally or from being put at risk of acting illegallyRight to protect self from damage claims

Completed CSA Rx

Patient namePatient addressDate writtenDrug, Quantity, DirectionsPhysician AddressPhysician DEA NumberPhysician Signature or NameOther information required by state

What can be changed by RPh?

Add or change patient’s address after verificationAfter consultation with prescriber, may change or add Dosage form Drug strength Drug quantity Directions for use Issue date

Brand-generic changeshttp://www.deadiversion.usdoj.gov/faq/general.htm#rx_change

FAXes (DEA Rules)

If can be telephoned, can be FAXedMake sure FAX paper will be readable for 2 years or reduce to writingPharmacist is responsible for verifying that FAX is not fraudulent Should show originating number on FAX FAX machines are programmable Call back prescriber at known phone to

verify

Schedule II FAXes

OK for “Authorization for Emergency Supply” according to DEA officialsCan fill a C-2 from FAX if compare to original written Rx prior to dispensingLong-term care facilities, may use as originalHome infusion practices - injectables only, may use as originalHospice patients, may use as original.

C-2

Filing CSA Rx’s

C-3,4,5C-3,4,5

“C”Legend

C-2

Legend

C-2C-3,4,5

“C”

LegendNot OK in WA

CSA Schedules: Basis and categories

Potential for abuseNarcoticsNon-narcotic stimulantsNon-narcotic CNS depressantsSteroidsPrecursors for CSAs

CSA Schedules

I - High potential for abuse and/or no medical useII - Highest potential for abuse Narcotic (eg, meperidine, codeine,

morphine, oxycodone) Non-narcotic stimulants (eg,

methylphenidate, amphetamine, phenmetrazine, methamphetamine)

Non-narcotic depressants (eg, barbiturates, methaqualone)

CSA Schedules - continued

III - Narcotic combinations and others Up to 90 mg codeine per dose plus other

active ingredients Hydrocodone plus APAP Doriden (glutethimide) Anabolic steroids (eg,

methyltestosterone) Benzphetamine and phendimetrazine Barbiturate suppositories

CSA Schedules - continued

IV - Primarily non-narcotics Benzodiazepines (eg, Valium, Halcion) Barbiturate combos (eg, Fiorinal) Meprobamate Phenobarbital Chloral hydrate Phentermine, mazindol, diethylpropion Propoxyphene dosage forms (powder = CII) Dichloralphenazone (component of

Midrin®) 9/01

CSA Schedules - continued

V - “Exempt narcotics” Low dose combinations of codeine

with other ingredients for diarrhea, pain, or cough -- some may be sold OTC

Diphenoxylate with atropine Generally no more than 10 mg

codeine per 5 mL (Tylenol w/ Codeine 12 mg/5mL)

Schedule II Rules

Products exchanged between registrants by use of DEA Form 222Power of attorney needed to order 222 forms and to sign them for the registrantWritten Rx required Date issued must be filled in Written signature of prescriber What can be changed on Rx by PharmD?

http://www.deadiversion.usdoj.gov/pubs/nwslttr/spec2000/policy.htm

No expiration date on Rx under federal law(1 yr in WA)

Emergency telephoned or FAXed Rx - Schedule II

Bona fide emergencySufficient quantity to last until written Rx can be providedWritten confirming Rx must be postmarked or received at pharmacy within 7 days ... if not received must notify BOP and/or DEA“Authorization for Emergency Supply” at top of telephoned (or FAXed) and written RxQuantity on written confirmation must match telephoned RxStaple written confirmation to telephoned Rx

Schedule II Rules - continued

Partial filling Out of stock ... must supply remainder

within 72 hrs and notify prescriber if remainder not supplied

Terminally ill ... partial filling for up to 60 days

Nursing home ... partial filling for up to 60 days

Label must bear “transfer warning”

Office-based Narcotic Maintenance Programs

Drug Addiction Treatment Act of 2000 (DATA)Allows for buprenorphine maintenance in selected physicians’ office practices as an alternative to methadone maintenance programs (MMPs)Prescribers must apply for a DATA waiverPharmacists may fill buprenorphine maintenance prescriptions with Subutex® or Suboxone®, but not other forms of buprenorphine, in community pharmaciesMethadone prescriptions not written in multiple daily doses for treatment of acute or chronic pain should be presumed to be for maintenance, and may only be dispensed in an authorized MMPThis program is one of only two exceptions to the rule that CSA’s may not be used to maintain an addiction

Limits on use of non-narcotic C-II stimulants in WA

Amphetamines, Dextroamphetamine, Phenmetrazine (Preludin®), MethylphenidateNarcolepsy, hyperkinesis, epilepsy, differential dx of depression, refractory depression, multiple sclerosis

Schedule III and IV Rules

Products exchanged between registrants by use of invoice with address and DEA # of eachMay be telephoned or FAXedMay refill up to 5 times within 6 months; Rx expires after 6 monthsMay transfer refills one time to another pharmacy if state law permits

Schedule III and IV Rules

Computer records must be kept on-line for 24 months after last possible refillIf use computer records, pharmacist must sign log sheet or bound book at end of each dayLabel must bear transfer warningTechnically, both date of first filling and of refilling must be on label

Partial filling of Schedule III & IV

Question: Is it permissible to dispense a prescription for a quantity less than the face amount prescribed resulting in the actual number of dispensings being greater than the number of refills indicated on the prescription?Answer: Yes. Partial refills of Schedule III, IV, and V controlled substance prescriptions are permissible under federal regulations provided that each partial filling is dispensed and recorded in the same manner as a refilling (i.e., date refilled, amount dispensed, initials of dispensing pharmacist, etc.), the total quantity dispensed in all partial fillings does not exceed the total quantity prescribed and no dispensing occurs after six months past the date of issue

http://www.deadiversion.usdoj.gov/faq/general.htm#prescrip

CSA Transfers

“VOID”Transferred toJones’s Pharmacy301 Miller StAnkenyDEA #PM131456711/15/97To: Bob Jones, RPhBy: Bill Fassett

“Transferred” from:Fassett Phcy1210 Ingersoll, DSMDEA #PF1021156 Rx # 101255By: Bill Fassett RPhDate Written: 10/1/97Dispensing History (*=Original)Date Rx # Pharmacy*10/1/97 101255 Fassett Phcy10/15/97 “ “ 11/1/97 “ “ Orig # Refills: 5 Refills Remaining: 3

Schedule V Rules - Legend Drugs

Products exchanged between registrants by use of invoice with address and DEA # of eachMay be telephoned or FAXedNo refill limit or expiration date for Rx under federal law (1 yr in WA)

Schedule V Rules - Legend Drugs

May transfer refills as allowed by state lawNo special computer records requiredExamples: Lomotil, Phenergan with Codeine, Tylenol with Codeine Elixir

Schedule V Rules - OTCsMay be sold (federal law) for medical use, with ID and proof of age 18 or over (21 in WA)Must be sold by a pharmacist (or intern in WA)

RPh or Intern must place initials, date, and name of pharmacy on bottle in WA

Record book must be maintained WA – record ID number of photo ID, initial record

book Copy sent to BOP when page is full or at end of every

month, whichever is sooner.

Substances and quantities of OTC C-V products

Opium-containing: up to 240 mL or 48 solid dosage forms

Only liquid antidiarrheals in WA

Others: up to 120 mL or 24 solid dosage forms within 48 hours

Only liquid cough syrups in WA

No more than 1 sale in 48 hours In WA, no more than 1 sale in 96 hours, or 2 sales in

60 days.

Examples: Parepectolin, Robitussin AC, Cheracol

RCW 4.24.510 – Protects persons who make reports to agencies

Communication to government agency or self-regulatory organization -- Immunity from civil liability. A person who communicates a complaint or information to any branch or agency of federal, state, or local government, or to any self-regulatory organization that regulates persons involved in the securities or futures business and that has been delegated authority by a federal, state, or local government agency and is subject to oversight by the delegating agency, is immune from civil liability for claims based upon the communication to the agency or organization regarding any matter reasonably of concern to that agency or organization. A person prevailing upon the defense provided for in this section is entitled to recover expenses and reasonable attorneys' fees incurred in establishing the defense and in addition shall receive statutory damages of ten thousand dollars. Statutory damages may be denied if the court finds that the complaint or information was communicated in bad faith.