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Controlled Substances Act

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					Controlled Substances Act

Valid CSA Prescriptions
To be dispensed to an ultimate user (patient) By an authorized prescriber In the due course of professional practice For a legitimate medical purpose

Authorized Prescribers
Up to state who can prescribe Must register with DEA and state DEA Number (eg, AJ0213455)
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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 schedules DMD, DDS – all schedules DVM – all schedules PodD, DPM – all schedules Any of the above in any state in the US
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British Columbia physicians can prescribe legend drugs, but not controlled substances unless have a US-issued DEA No.

Mid-level practitioners in WA
ARNPs
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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 MD Optometrists – limited drug list, may include III, IV, V
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Pharmacists – any schedule within scope of authorizing prescriber Others who are not physicians, dentists, or veterinarians (none authorized currently in WA)

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”

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 prescribe Unregistered VA employees, likewise Use hospital DEA # plus internal code; must add stamped, printed, or typed name as well as signature May be filled at community pharmacies

Due Course of Practice
Bona fide patient-physician relationship
Within scope of practice

Within scope of practice
Physician - entire human body Dentist - head and neck Podiatrist - ankles and feet Nurse practitioner - specialty area Physician assistant - same as supervising physician

Within scope of practice
Optometrist - eyes Ophthalmologist - same as physician Psychiatrist - same as physician Psychologist - not generally allowed to prescribe Veterinarian - entire animal body Pharmacist - humans, within scope of authorizing practitioner

Legitimate Medical Purpose
Not “for office use” Not fraudulent nor forged Not 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
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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 uses Civic duty to prevent/report crime vs professional duty to treat Right to protect self from being forced to act illegally or from being put at risk of acting illegally Right to protect self from damage claims

Completed CSA Rx
Patient name Patient address Date written Drug, Quantity, Directions Physician Address Physician DEA Number Physician Signature or Name Other information required by state

What can be changed by RPh?
Add or change patient’s address after verification After consultation with prescriber, may change or add
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Dosage form Drug strength Drug quantity Directions for use Issue date

Brand-generic changes http://www.deadiversion.usdoj.gov/faq/gener al.htm#rx_change

FAXes (DEA Rules)
If can be telephoned, can be FAXed Make sure FAX paper will be readable for 2 years or reduce to writing Pharmacist is responsible for verifying that FAX is not fraudulent
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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 officials Can fill a C-2 from FAX if compare to original written Rx prior to dispensing Long-term care facilities, may use as original Home infusion practices - injectables only, may use as original Hospice patients, may use as original.

Filing CSA Rx’s
C-2
C-2 C-3,4,5 “C” Not OK in WA Legend

C-2

C-3,4,5 Legend

C-3,4,5 “C” Legend

CSA Schedules: Basis and categories
Potential for abuse Narcotics Non-narcotic stimulants Non-narcotic CNS depressants Steroids Precursors for CSAs

CSA Schedules
I - High potential for abuse and/or no medical use II - Highest potential for abuse
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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
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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
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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”
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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 222 Power of attorney needed to order 222 forms and to sign them for the registrant Written Rx required
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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/s pec2000/policy.htm

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

Emergency telephoned or FAXed Rx - Schedule II
Bona fide emergency Sufficient quantity to last until written Rx can be provided Written 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 Rx Quantity on written confirmation must match telephoned Rx Staple written confirmation to telephoned Rx

Schedule II Rules - continued
Partial filling
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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 waiver Pharmacists may fill buprenorphine maintenance prescriptions with Subutex® or Suboxone®, but not other forms of buprenorphine, in community pharmacies Methadone 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 MMP This 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®), Methylphenidate Narcolepsy, 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 each May be telephoned or FAXed May refill up to 5 times within 6 months; Rx expires after 6 months May 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 refill If use computer records, pharmacist must sign log sheet or bound book at end of each day Label must bear transfer warning Technically, 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 to Jones’s Pharmacy 301 Miller St Ankeny DEA #PM1314567 11/15/97 To: Bob Jones, RPh By: Bill Fassett

“Transferred” from: Fassett Phcy 1210 Ingersoll, DSM DEA #PF1021156 Rx # 101255 By: Bill Fassett RPh Date Written: 10/1/97 Dispensing History (*=Original) Date Rx # Pharmacy *10/1/97 101255 Fassett Phcy 10/15/97 “ “ 11/1/97 “ “

Orig # Refills: 5

Schedule V Rules - Legend Drugs
Products exchanged between registrants by use of invoice with address and DEA # of each May be telephoned or FAXed No 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 law No special computer records required Examples: Lomotil, Phenergan with Codeine, Tylenol with Codeine Elixir

Schedule V Rules - OTCs
May 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)
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RPh or Intern must place initials, date, and name of pharmacy on bottle in WA 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.

Record book must be maintained
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Substances and quantities of OTC C-V products
Opium-containing: up to 240 mL or 48 solid dosage forms
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Only liquid antidiarrheals in WA

Others: up to 120 mL or 24 solid dosage forms within 48 hours
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Only liquid cough syrups in WA
In WA, no more than 1 sale in 96 hours, or 2 sales in 60 days.

No more than 1 sale in 48 hours
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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 selfregulatory 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.


				
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