Controlled Substances Flashcards
MPJE MadeEasy
Schedule I drugs
-Methaqualone
-Heroin
-Mescaline
-GHB (Gamma Hydroxybutyric Acid
-LSD
-Marijuana
-Peyote
-THC
Schedule II drugs
-Amobarbital
-Cocaine
-Fentanyl (Duragesic, Actiq, Fentora, Lazanda)
-Meperidine (Demerol)
-Methamphetamine (Desoxyn)
-Amphetamines (Dexedrine, Adderall)
-Diphenoxylate
-Hydromorphone (Dilaudid)
-Methadone (Dolophine)
-Methylphenidate (Ritalin, Concerta)
-Morphine
-Oxycodone (Tylox, Percocet, Percondan)
-Pentobarbital (Nembutal)
-Oxymorphone (Opana)
-Nabilone (Cesamet)
-Hydrocodone/APA (Vicodin, Lorcet)
-Hydrocodone/Chlorpheniramine (Tussionex)
-MS Contin
-Oxycontin
-Secobarbital (Seconal)
-Tapentadol (Nucynta)
-Codeine
-Hydrocodone
-Hydrocodone/Ibuprofen (Vicoprofen)
Schedule III Drugs
-Anabolic steroids
-Buprenorphine (Subutex)
-Fiorinal/Codeine
-Dronabinol (Marinol)
-Hydroxybutyric acid, sodium oxybate (Xyrem) –> must note the medical use of drug on rx face when prescribed
-Codeine/ASA
-Buprenorphine/Naloxone (Suboxone)
-Paregoric
-Tylenol/Codeine
Anabolic Steroids (Schedule III Drugs)
-Ethylesternol (Maxibolin)
-Stanozolol (Winstrol)
-Testosterone Patch (Androderm, Testoderm)
-Methandrostenolone (Dianabol)
-Nandrolone deconoate (Deca Durabolin)
-Flupxymesterone (Halotestin)
-Oxandrolone (Anavar)
-Oxymetholone (Anadrol)
Schedule IV Drugs
-Alprazolam (Xanax)
-Chloral Hydrate (Noctec)
-Clonazepam (Klonopin)
-Diazapam (Valium)
-Butorphanol (Stadol)
-Chlordiazepoxide (Librium)
-Clorazepate (Tranxene)
-Ethchlorvynol (Placidyl)
-Flurazepam (Dalmane)
-Oxazepam (Serax)
-Zolpidem (ambien)
-Midazolam (Versed)
-Carisoprodol (Soma)
-Zaleplon (Sonata)
-Lorazepam (Ativan)
-Pentazocine (Talwin)
-Tremazepam (Restoril)
-Halazepam (Paxipam)
-Mazindol (sanorex)
-Triazolam (Halcion)
-Modafinil (Provigil)
-Eszopiclone (Lunesta)
Schedule V Drugs
most are cough suppressants and anti-diarrhea drugs
-Actifed/Codeine
-Novahistine Expectorant
-Promethazine/Codeine
-Guaifenson/Codine
-Lomotil
-Novahistine DH
-Promethazin VC/Codeine
-Acetaminophen/Codeine Liquid
-Pregabalin (Lyrica)
Maximum Ingredient of Codeine
-1.8 gram/100 ml
-90 mg per dosage unit
Maximum Ingredient of Dihydrocodeine
-1.8 gram/100 ml
-90 mg per dosage unit
Maximum Ingredient of Ethylmorphine
-300 mg per 100 ml
-15 mg per dosage unit
Maximum Ingredient of Opium
-500 mg per 100 ml
-25 mg per dosage unit
Maximum Ingredient of Morphine
-50 mg per 100 ml
Who has drug scheduling authority?
-Attorney General
–> the AG must request a scientific and medical evaluation of the drug from the secretary of the Department of Health and Human Services (HHS)
-if the AG finds that a drug must be places into schedule I to avoid an “imminent hazard to public safety”, he/she may do so w/o consulting the Secretary of HHS
When is emergency (telephone order) of schedule II drugs permitted?
-immediate admin of schedule II substance is needed
-no alt tx is available
-it is not reasonably possible for the prescriber to present a written prescription prior to dispensing
What are the requirements related to emergency dispensing?
-the quantity dispensed should only be enough to get the patient through the emergency period
-the rx must be immediately reduced to writing
-effort must be made to ascertain that the oral authorization came from a registered individual practitioner
-within 7 days, the physician must have delivered (or postmarked) a rx to the pharmacy, with the words “authorization for emergency dispensing” *diff for PA
-pharmacist must attach the written rx to the oral emergency written rx
–> failure of the physicial to deliver a written rx requires that the rph notify the DEA
—–> failure to notify the DEA voids the authority of the pharmacy to accept emergency oral orders for schedule II substances
*in the event that the prescriber sents electronic rx instead of writtern, the rph must annotate the record of the electronic rx with the original authorization and date of the emergency oral order
Under PA law, what is the time frame in which the delivery of the hard copy of an rx after emergency verbal?
within 72 hrs (federal states within 7 days)
How do you partial fill schedule II rxs when the pharmacy does not have enough stock to fill rx?
-the amount must be noted on the face of the rx
-if the balance is unable to be filled or is not filled within 72 hrs, the pharmacist must notify the prescriber–> either to get a new rx for the balance owed or to let them know the RX was not completely filled
Exceptions to the 72 hrs rule for Schedule II partial fills: Long term care facilities
may dispense partial quantities of schedule II rxs up to 60 days
-must record: date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed & the identification of the dispensing rph
Exceptions to the 72 hrs rule for Schedule II partial fills: Terminally ill pts
-pharmacists may dispense partial quantities of schedule II rxs up to 60 days to pts with diagnosis of a terminal illness
-must record: date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed & the identification of the dispensing rph
What is the Comprehensive Addiction and Recovery Act (CARA)?
-allows a rph to partial fill schedule II drugs when requested by the pt or prescriber, as long as the practice is not prohibited by state law
–> any remaining portion must be filled within 30 days that rx was issued
When is the partial filling of a CIII-DV allowed?
-each partial filling is recorded in the same manner as a refill
-total quantity dispensed in all partial fillings does not exceed the total quantity prescribed
-no dispensing occurs beyond 6 months after the rx is issued
*only 5 refills are allowed but greater than 5 partial fillings are allowed!
Filing methods for controlled drug RXs (federal) - rules
-schedule II shall be maintained in a separate rx file
-schedule II, IV, V shall be maintained in a separate file and are “readily retrievable”
–> readily retrievable means: the face of the rx is stamped in red ink in the lower right corner with a letter C no less than 1 in high, filed in the rx file for controlled substances listed in schedule II or in the rx filed for non controlled substances
*red C is waived under federal law for electronic rxs (PA waived red C on electronic CS rx but is silent on paper rxs)
Filing methods for controlled drug RXs (federal) - 3 different methods
“3-2-2” Filing Method
A. separate [schedules II], [schedule III-IV] and [non-controlled Substances]
B. separate [schedule II] and [III-V, non-controlled substances]
C. separate [schedule II, III-V] and non-controlled substances
Filing methods for controlled drug RXs (PA law) - 2 different methods
A. separate [schedules II], [schedule III-IV] and [non-controlled Substances]
B. separate [schedule II] and [III-V, non-controlled substances]
*must keep CIIs separate
Inventory Requirements for Controlled Substances
-Biennial inventory requirements
-newly scheduled drugs must be inventoried the day that they become scheduled and then again with the next scheduled biennial inventory
-schedule I and II drugs need to be counted EXACTLY
-schedule III, IV & V drug counts can be estimated unless the original container from the manufacture contained more than 1,000 tabs - then an exact count must be taken
-Inventory recorded must be maintained for 2 years at the inventory location
-Inventory must be taken at beginning or close of business and time must be recorded on inventory record
-inventory must be taken if there is a change in ownership
-inventory records for CII must be kept separately
-Inventory records for CII-V must be “readily retrievable”
Central Record keeping
-permitted by the DEA provided that they are notified 14 days in advance, in triplicate, by registered or certified mail, return receipt requested
–> must tell DEA what records will be kept centrally, their exact location, name, addy, DEA # and type of registration, & whether manual or computerized, access codes etc
–> upon request, registrant must provide records to the registered location within 2 business days
–> failure to comply may result in canceling the central record keeping authorization
**central record keeping MAY NOT include: rxs, inventory records, and executed 222 order forms
*** MAY include unexecuted 222 order forms
Ordering Procedure for CII substances (DEA Form 222)
-forms may be requisitioned by using DEA form 222a
-when completing a single sheet DEA 222 order form, the pharmacy must make a copy of the original DEA 222 form for its records, copy may be kept in electronic or paper form –> supplier retained the original copy and submits a copy to the DEA
DEA form 222 fun facts
-no alterations or white outs are permitted –> if a mistake is made: mark the DEA form “VOID” and store with other executed order forms do NOT throw away
-DEA 222 may be signed by the registrant or by someone who has been given the power of attorney to execute the form
-if an order cannot be filled completely, the supplier has 60 days from the date of the execution of the order form to supply the balance
-the supplier can also “endorse” the reverse side of the DEA 222 form to another supplier if they dont have the item ordered
-order froms for Carfentanil, Etorphine Hydrochloride and Diprenorphine shall contain only these substances
DEA form 22 fun facts: part 2
-very important for the purchaser to record the number of containers received and the date received on part 5 of the DEA 222 form
-a purchaser may cancel part or all of an order by notifying the supplier in writing. The supplier must indicate the cancellation by drawing a line through and marking the item “cancelled”
-A supplier may void part or all of an order on a DEA 222 by notifying the pharmacy in writing. the supplier must indicate the voiding on the original DEA form by drawing a line through the cancelled item(s) and printing “void” in the space provided for the number of items shipped. the supplier would then send the original 222 order form back to the pharmacy along with an explanation - pharmacy would retain the voided 222 form and the explanation in its records
Single sheet 222 form
-sept 30, 2019- DEA changed from triple 222 to single 222 (2 yrs transition period)
-new sheet is 8 1/2 x 11 inch sheet and expands the number of items that may be ordered from 10 to 20
Controlled substance ordering systems (CSOS) electronic order forms
-any registrant permitted to order schedule II controlled substances may do so electronically via the CSOS and maintain the records for 2 yrs (electronically)
-CSOSO uses public key Infrastructure (PKI) technology, which requires CSOS users to obtain a CSOS digital certificate for electronic ordering - electronic orders must be signed using a digital signature issued be a certification authority* run by the DEA.
-a registrant must appoint a CSOS coordinator who will serve as that registrant’s recognized agent regarding issues pertaining to issuance of, revocation of, and changes to, digital certificates issued under that registrant’s DEA registration
An electronic order for a CS may not be filled if any of the following occurs:
-the required data fields have not been completed
-the order is not signed a digital signature issues by DEA
-the digital certificate used has expired or been revoked prior to signature
-the purchaser’s public key will not validate the digital certificate
-the validation of the order shows that the order. is invalid for any reason
how to cancel and void an electronic order
-supplier may void all (or part) of an electronic order by notifying the purchaser of the voiding
-if the entire order is voided, the supplier must make an electronic copy of the order and indicate “void” on the copy and return it to the purchaser
-supplier is not required to retain a record of orders that are not filled
-purchaser must retain an electronic copy of the voided order
-should a supplier partially void an order, the supplier must indicate in the linked record that nothing was shipped for each item voided
How to proceed with lost electronic orders
-purchaser must provide, to the supplier, a signed statement: including the unique tracking number and date of the lost order & state that the goods covered by the first order were not received through loss of that order
-if the purchaser executes a new order to replace the lost order, the purchaser must electronically link an electronic record of the second order and a copy of the statement with the record of the 1st order and retain them both
DEA records for Electronic Orders
-for each electronic order filled, a supplier must forward either a copy of the electronic order or an electronic report of the order in a format that DEA specifies to DEA within 2 business days.
Electronic Prescriptions for Controlled Substances
-the rule provides practitioners with the option of writing prescriptions for controlled substances electronically and for pharmacies to receive, dispense, and archive these electronic prescriptions
DEA application requirements for electronic prescribing of CSs
-pharmacy cannot process electronic rxs for CSs until its pharmacy application provider obtains a 3rd party audit or certification review that determines that the application complies with DEA’s requirements and the application provides the audit/certification report to the pharmacy.
Avoiding duplicate filling: simultaneous paper and electronic prescriptions
-when a pharmacist receives a paper or oral rx that indicates that it was originally transmitted electronically to the pharmacy, the rph must check the pharmacy’s records to ensure that the electronic version was not received and the rx dispensed
–> if both prescriptions were received, the pharmacist must mark one as void
What is the Ryan Haight Online Pharmacy Consumer Protection Act?
act amends the CSA to prevent the illegal distribution of CS on the internet
-effective 4/13/09- pharmacies must get a modification of existing DEA registration to allow operation of an online pharmacy
What are exemptions of the Ryan Haight Online Pharmacy Consumer Protection Act?
-pharmacies registered with the DEA whose dispensing of controlled substances via the internet consist soley of refilling tx for CS in schedule II, IV, V
-or filling a new rx in schedules III, IV, V where the pharmacy has previously filled a non-internet rx for the same pt
what are additional requirements (on home page of website) of the Ryan Haight Online Pharmacy Consumer Protection Act?
-statement that the pharmacy complies with the act
-name, addy, e-mail and phone # of the pharmacy
-name, professional degrees, and states of licensure for the pharmacist in charge & a # they can be called at
-list of states in which the pharmacy is licensed
-certification that pharmacy is registered with DEA as on online pharmacy
-name and contact of any practitioner who has contractual relationships with the pharmacy
Verified Internet Pharmacy Practice Sites steps
-obtained a verified Internet pharmacy practice site (VIPPS) accreditation from NABP
-obtain a pharmacy domain for their website (www.deeznuts.pharmacy)
-must register with DEA 30 days prior to engaging in internet pharmacy involving CSs
-monthly reports must be made to the DEA of the quantity of each CS dispensed
Online Pharmacy: In Transit Losses
-supplier is responsible for reporting the in-transit loss of controlled substances to the DEA
-if discovered that an in-transit loss or theft has occurred; the purchaser must then submit a DEA Form 106
What to do is a DEA 222 order form has been lost or stolen in transit?
-pharmacy executes another order form and attaches a statement with:
–the order form number
–the date of the lost form
–a statement starting that the goods covered by the first order were not received through loss of that order form
-a copy of the second form and a copy of the statement must be retained with a copy of the original order at the pharmacy
-if the original form is received by supplier - mark it “not accepted” and return to pharmacy
What to do if DEA 222 forms are lost/stolen NOT in transit
-immediately report to the special agent in charge of the Drug Enforcement Administration in the Divisional Office responsible for the area in which the registrant is located, stating the serial number of each form stolen or lost
Registration requirements for controlled substance activity
-pharmacies are required to register with the Attorney General every 3 yrs (pharmacists are not required to register individually)
-separate registrations for each pharmacy owned or operated by the same firm are required under DEA regulations
-manufacturers & distributors must register annually
**pharmacy may “distribute” CS to another pharmacy or physician without having to register as a distributor, provided that such sales amount to less than 5% of all CS dispensed & distributed in a year
Registration requirements for controlled substance activity- who is EXEMPT?
-practitioner working in a hospital
-physicians who are officials of the Armed Services, Public Health Services, and Bureau of Prisons (who are also allowed to dispense, administer, and prescribe in the usual course of their official duties
-other duly authorized law enforcement personnel are exempt from registration for possession of CS as part of their official duties
What is the controlled substance registration application process?
-pharmacy initially completes application - DEA 224
-can renew online no more than 60 days prior to the current expiration date by completing a DEA 224a application
–> if pharmacy does not renew online within 50 days of expiration, one will be sent to addy
-if form is not received within 30 days before expiration - pharmacy should contact the local DEA registration specialist or DEA headquarters
Modification of Controlled substance registration
e.g. change of address, addition of schedules etc
- must notify the DEA in writing
-if approved, DEA will issue a new certificate, which must be maintained with the old certificate
Termination of Controlled substance registration
-if an individual registrant dies, or an individual registrant ceases legal existence, or d/c business, the DEA must be notified
Transfer of Controlled substance registration
no registration may be transferred or assigned w/o the approval of the DEA after submitting a written request
Who can deny a CS registration?
the attorney general
When would a CS registration be revoked or suspended?
Attorney General may do so if applicant has:
-materially falsified the application
-has been convicted of a felony relative to CS
-has had a state license or registration suspended, revoked, or denied
–> before this, DEA must issue an order to show cause upon the registrant, who then must deliver the Certificate of Registration and all 222 forms to the DEA (gives the person an opportunity to defend themselves)
Separate registrations for CS are normally required for:
-manufacturing
-distributing
-reverse distributing
-dispensing/Instructing
-research
-importing
-exporting
-narcotic treatment program
-chemical analyses
4 ways to destroy controlled substances
-destroy using an on-site method (for pharmacies that have modified DEA registrations that allow them to be collectors)
-deliver the CS to a reverse distributor’s registered location by common or contract carrier pick-up
-for return/recall: deliver to the registrants registered location (the manufacturer)
-request assistance from the special agent in charge of the administration
–> request can be made by submitting 1 copy of DEA form 41
What is DEA form 41 and what happens after it is submitted?
-DEA 41 lists the CS or substances which the registrant desires to dispose
-Special agent then disposes drugs by:
– transfer to a registrant authorized to transport or destroy the substance
– delivery to an agent of the administration or to the nearest offie of the Administration
– by destruction in the presence of an agent of the Administration or other authorized person
How do reverse distributors destroy CSs?
-(reverse distributor can return controlled substances to manufacturer or dispose of them on their behalf)
-RD fills out a 222 form for any schedule II substances being destroyed
-pharmacy records the drug name, dosage form, strength, quantity and date of transfer from any CIII - CIV
-RD (NOT the pharmacy) is responsible for completing the DEA form 41 once the drugs are destroyed
What is the Final Rule for the Disposal of Controlled Substances?
-became effective October 9, 2014
-sets requirements for DEA registrants that voluntarily decide to establish disposal programs to collect unwanted CS from ultimate users
–> allows numerous DEA registrants to become authorized to establish disposal programs (manufacturers, distributors, reverse distributors, narcotic tx programs, hospital, pharmacies)
–> allows a number of disposal program including mail-back programs, collection receptacles and collection events (authorized only by law enforcement)
-requires destruction of CS, no particular way
What to do if a CS has been lost or stolen:
-notify the DEA in writing within ONE business day (fax) via a DEA form 106
–> if no theft, then no 106 but still write the DEA & tell them why no DEA form 106 was filed
-the registrant must also file a complete and accurate DEA form 106 with the Administration through DEA’s Diversion Control Substance secure network application within 45 days after discovery of the theft or loss
Restrictions for CS Prescriptions
-rx may not be issued for Methadone for detoxification or maintenance tx. however, methadone can be dispensed in a retail pharmacy for analgesic purposes
What are the requirements for CS rxs
-may be written on prescription blanks or may be oral
-dates, signed, pts full name, address
-drug name, strength, dosage form, quantity prescribed, directions
-name, addy and DEA # of prescriber
-manual sig of physician
-DEA number cannot be reprinted on the rx
Allowable changes to a CS rx (Schedules III-IV)
A Pharmacist may:
-add the pts addy or change the pts addy upon verification
-change or add the dosage form, drug strength, drug quantity or directions for use, only AFTER consultation w/ and agreement of the prescribing practitioner
–> pharmacist is NEVER permitted to make changes to the pts name, CS prescribed (except for generic sub) or the prescribers signature
When transferring a CS rx, the transferring pharmacist must record
-“VOID” on the face of the rx
-name, addy and DEA od the transferee pharmacy
-name of the transferee pharmacist
-date the prescription was transferred
-pharmacist that transferred the prescription
Controlled drug prescription transfer
-permissible as a one-time basis only!
-pharmacies electronically sharing a real time, on-line, database may transfer up to the max refills allowed by state
When transferring a CS rx, the transferee pharmacist must recors
-“transfer” on the face of the rx
-date of issue of the original rx
-original number of authorized refills
-original date of dispensing
-number of valid refills remaining and the dates and location of the previous fills
-pharmacy name, addy, DEA number, and the rx number from which the rx information was transferred
-name of the pharmacist who transferred the rx
-pharmacy name, addy, DEA #, and rx number from which the rx information was originally filled
Transfer of UNFILLED electronic prescriptions for initial filling
-DEA implemented (Aug 2023) a law that allows the transfer of unfilled electronic prescriptions for CS for initial filling, upon request from the pt - applies to CIIs as well
-when CIII-IC CS rx is issued with authorized refills, they are transferred with the original prescription
PA Pharmacy Act has provision that states that CIIs may NOT be transferred
Retrieval and storage of CS refills: Manual system
-pharmacist must initial and date the back of the rx for each refill
-refills are allowed on substances III-V w/ a max of 5 times or over a period of 6 months, whichever comes first , to the extent allowed by the physician
Computer requirements to be able to store controlled substances refill information
-on-line retrieval of original prescription order information
-on-line retrieval of the current refill hx
-documentation that any refill information entered in the computer is correct (rph must generate a printout of each days CS refill data, verify, date and sign it)
-capability of printing out refill information
-auxiliary procedure to document refills in the event of system downtime
Additional refills for CS rxs
Practitioner may authorize refills of schedule III-V provided that:
-total quantity authorized, including original does not exceed 5 refills nor extend beyond 6 months from the date of issue
-the rph initials and records the date, quantity authorized, & the # of additional refills authorized on the reverse of the original rx
-the quantity of each additional refill is equal to or less than the quantity authorized for the initial filling
-a new rx is required for any refills beyond the 6- month, 5 refill limit
Inspections under the CSA
Before an inspection, the inspector is required to:
-state the purpose of the inspection
-present credentials
-provide a written Notice of Inspection (rph has the right to refuse unless a search warrant or an Administrative Inspection Warrant is issued)
–> an AIW is issued by a judge given a probable cause of serving “a valid public interest”
Special requirements for mailing Controlled Substances
-must be placed in a plain outer mailing container or securely over-wrapped in plain paper
-the inner container must also be labeled to show the prescription # and the name and address of pharmacy, practitioner, or other person dispensing the rx
-the outer mailing wrapper or container is free of markings that indicate the nature of the content
Facsimile Prescriptions (rules for faxing)
Faxing of CII rx is allowed, but before dispensing, the rph must generally receive the original signed RX for review, except for a fax for:
-a CII to be compounded for direct admin to pt by parenteral, IV, IM, SQ or intra-spinal infusion
-a CII narcotic for a hospice pt
-any CII for a pt in a long term care facility
*CSA permits faxed rx for C III-V (and non controlled substances) to serve as original rxs
For what treatment is the dispensing of methadone (Dolophine) allowed in the retail setting?
-analgesic purposes only
–> for addicts, tx with methadone is only allowed in a methadone clinic
What are the exceptions for permitting Methadone dispensing outside a clinic?
-dispensing by a physician over a 3 day period while in the process of enrolling a pt in a clinic
-administering to a pt while hospitalized for a condition unrelated to the addiction
-for intractable pain (terminal cancer pt)
Opioid Treatment Program (OTPs) ran by SAMHSA
AKA methadone clinics: allow physicians to provide medication - assisted tx (MAT) - combines use of meds w/ behavioral health services
-> must obtain approval and certification from the substance abuse and mental health services admin (SAMHSA) & from the state methadone authority
–> must also register with the DEA as a Narcotic tx program via a DEA form 363
What medications (C II) are allowed to be used in opioid treatment programs?
-methadone
-levo-alpha-methadol (LAAM)
(Buprenorphine and Buprenorphine - Naloxone are allowed but are C III)
What is Detoxification treatment?
-the dispensing of an opioid tx med in decreasing doses to an individual to alleviate adverse physiological or effects incident to withdrawal
–> short term: period not in excess of 30 days
–> long term: period more than 30 days but not in excess of 180 days
What does the term maintenance treatment mean?
-the dispensing of an opioid agonist tx med at stable doses for a period in excess of 21 days
What did the Drug Addiction act (DATA) of 2000 do?
-expanded the tx of opioate addicts beyond the clinic - allows for the use of Buprenorphine (Subutex- initial tx) and Buprenorphine & Naloxone (Suboxone- maintenance) C-IIIs to be dispensed in a retail pharmacy for tx of opiate addiction
What did the Consolidated Appropriation act of 2023 do?
Prescribers are no longer required to obtain a DATA waiver (Xnumber) to tx pts with buprenorphine for opioid use disorder –> all rx require a DEA registration #
-no longer a cap/limit on the number of pts a prescriber may treat for opioid use disorder w/ buprenorphine
-one-time training requirement for all controlled substance prescribers (not dentists and vets) - 8hrs CE
Storage of CSs in emergency kits
may place in non-DEA registered Long term care facility must delineate:
-source of CS
-security safeguards 9who may access, limitation of the type & quantity of CS permitted in the kit)
-responsibility for proper control and accountability
-emergency medical condition’s under which the CSs may be administered
- prohibited activities (that if violated could result in state revocation, denial or suspension of the privilege)
Labeling requirements for Commercial packages of Controlled Substances
Verifying a DEA number
-2 alpha characters followed by 7 digits (2nd letter = first letter of practitioner last name)
-physician DEA #s will begin with A, B, F, G)
-mid level prac begin with M
-wholesaler DEA begin with P or R
1) Add the second, fourth, and sixth digits TIMES 2.
2) To this subtotal, add the first, third, and fifth digits.
–> The last digit of the total should correspond with the last digit of the DEA number
In PA, what must a CS prescription label contain?
-name and addy of the pharmacy
-phone # and DEA # of pharmacy
-Serial # & date of initial dispensing
-name of pt and prescribing practitioner
-directions for use and cautionary statements including Caution: federal law prohibits transfer of those drug to any person other than the pt for whom it is prescribes”
-the trade or brand name of the drug, strength, dosage from and quantity dispensed (if generic- manufacture’s name will also be shown)
- reqs waived for institutional pts if:
- CII dispensed in no more than 7 ds
-C III- V drug is dispensed in a 34 day supply or 100 unit doses (whichever is less)
What is requires to be on a CS rx label (central fill)
-retail pharmacy name and addy
-a unique identifier (central fill pharmacy DEA #)
Central Filling of CS: transmitting Pharmacy reqs
-transmitted electronically from the retail (transmitting) - must write “central fill” pharmacy on the face of the rx and record the name, addy, and DEA # of the central fill pharmacy, name of transmitting pharmacist and date of transmission
Central Filling of CS: Central fill pharmacy requirements
-must keep a copy of the rx if fax or an electronic record of the info sent: name, addy, and DEA number of the transmitting pharmacy
-keep a record of the date of receipt of the transmitted prescription, the name of the pharmacist filling the prescription, and the date of filling, record of the date delivered to the retail pharmacy and the method of delivery.
Veterinary Prescribing CS
-may prescribe, administer, or dispense a CS
–> in good faith in the course of his/her practice &
–> not for the use by a human (*alert where physician is attempting to write a rx for an animal or a vet tryna write one for a human - both not allowed)
-rx for CS for an animal would not list the animals name- the species of the animal and the name & addy of the owner
Controlled Substance Registration Protection Act
-mandates that a federal investigation result if:
1- replacement cost of CS taken is $500 +
2- registrants or other person is killed or suffers injury
- burglary or robbery: max $25k fine and/or 20 yrs jail
-dangerous weapon used: max $35k fine and/ore 25 yrs jail
- death results = max $50k fine and/or life in jail
3- interstate or foreign commerce is involved in planning or execution of the crime
Distribution of CS upon discontinuance of a Business: NOT transferring the business activity
-return the certificate of registration, any unused 222 forms tot he DE at the Washington DC office
-must also complete a DEA 41 form & wait for a response on how to dispose the CSs
Distribution of CS upon discontinuance of a Business: transferring the business activity
-when transferring to another person: must submit the proposal to the DEA 14 days in advance & include:
–> name, addy and DEA # of the registrant d/cing the business as well as the same info for the registrant acquiring the business
–> whether the business activities will continue at the current location or not
-unless the DEA says no, the transfer can occur, and on the day of the transfer a complete CS inventory must be taken (transfer of CIIs must be done via 222 form)
-CS records are also transferred
Misc CS considerations
-records required must be kept by the registrant for 2 yrs
-no DEA registrant can employ an individual who has access to CS if they have a previous felony offense related to CSs, had an application for CS registration denied, revoked or suspended (can ask DEA for waiver if they are in this situation)
-under federal law- no specific quantity limit for a CS rx
-under federal law- no specific time limit during which a C II must be filled: PA placed a 6 month limit from the date of rx issue
Sales limits on Scheduled Listed Chemical Products (SLCP)
-daily sale limit on Retailers: may not exceed 3.6 gram (base) per day per purchaser
-30 day purchase limit on consumers: cannot purchase more than 9 g (base)
-Mail order limits: may not sell more than 7.5 gram (base) within a 30 day period
*Calculating allowable quantities based on the amount of BASE in the product
-Ephedrine HCL 25 mg has 20.57 mg base
-Pseudoephedrine HCl 30 mg tab has 24.65 mg base
–> can purchase 146 tabs per day of Sudafed 30 mg
-Pseudoephedrine S)4 30 mg tab has 23.22 mg base
Other restrictions on Scheduled Listed Chemical Products (SLCP)
-all SLCP products must be kept behind the counter or in locked display on the floor
-written or electronic logbook of transactions
–> must include: Warning section 1001 of title 18: if someone makes false doc: $250,000 fine for individual, $500,000 fine for organization and/or 5 yrs jail
-each entry must be maintained for 2 yrs following the date of entry
-need to have photo ID
- any loss or disappearance must be reported to the DEA orally ASAP, followed by a written report within 15 days
Training Employees to dispense Scheduled Listed Chemical Products (SLCP)
-submit self-certifications to the Attorney General - kept updated on an annual basis
-The Attorney General may prohibit persons who sell products in violation of the
sales restrictions or the logbook, training, and certification requirements from selling any SLCPs
- Retail stores may take reasonable measures to guard against employing
individuals who may present a risk with respect to the theft and diversion of SLCP products
What is the NPLEX? PA LAW
Pharmacies must submit sales of SLCP’s via the National Precursor Log Exchange (NPLEX) - keeps track of OTC pseudoephedrine and ephedrine
-provides real time tracking and alerts the pharmacy if an individual attempts to purchase more than legal limits
Issuance of multiple Rxs for CII CSs
-individual practitioner may issue multiple rxs authorizing a pt to receive up to a total of 90 ds - must meet conditions:
1- each rx is issued for a medical purpose
2- writes instructions on each rx- indicating earliest fill date
3- practitioner concludes that providing the patient with multiple rxs does not create risk of diversion or abuse
4- permitted by law
*even though some have the “do not fill until”, they are all still dated as of the same date of issue
What is the Achieving Better Care by Monitoring All Prescriptions Program (ABC-MAP)? PA LAW
-database contains info on dispensed CS II-V
-RPH & other authorized HCPs can access the database in order to better recognize signs of diversion and “doctor shopping”
-HB 602 Act 53: required that all who sell Pseudoephedrine OTC submit electronic transactions to NPLEX by april 5, 2014.
(replaced former submission of CII data on a monthly basis to Attorney Generals office)
ABC-MAP- pharmacy requirements for submission PA LAW
within 1 business day of dispensing CS must record:
-name of prescriber
-prescriber DEA, NPI #
-date the rx was written
-date it was filled
-name, DOB, gender and addy of pt
-NDC # of the drug dispensed, quantity and DS
-number of refills authorized & refill #
-DEA, NPI of pharmacy
-payment method pt used
ABC-MAP- when pharmacy is required to check data base PA LAW
before dispensing an opioid or benzo to a pt if:
- pt is new to the pharmacy
-pt pays cash when they have insurance
-pt requests an early refill
-pt is getting opioids or benzos from more than 1 prescriber
ABC-MAP- What is a pharmacy to do not dispense any CSs PA LAW
-submit a zero-report to notify the PDMP office that it did not dispense any on a given business day
–> pharmacies who never dispense a CS or dispense less than 5 CS/month can request a waiver from submitting zero-reports
What is an agent of the prescriber?
-a prescriber may authorize a non employee agent to transmit a prescription for a controlled substance to a pharmacist
-creates a vehicle
(written agent agreement) for individuals acting outside of an employer/employee relationship to be considered agents of the prescriber.
What activities can an authorized agent of the prescriber engage in?
-prepare a CS rx for the signature of the prescriber
-orally communicate a prescribers C III, C IV or C V rx to a pharmacist or via practitioner-signed fax
-transmit by fax a prescriber’s written C II rx to a pharmacist for a pt in hospice or LTFC
Emergency oral communication of C-II prescription may not be delegated to an authorized agent
Opiate Prescribing for Minors PA LAW
Provider must have a consent form signed by a parent or authorized adult, as well as advising on the risks and dangers of opioids, etc.
-The prescriber also cannot prescribe more than a 7 days’ supply of an opioid to a minor (72-hour supply if the individual
who signs the consent form is an authorized adult and not the parent)
- if in the professional medical judgment of the prescriber, more than a seven-day supply of a CS containing an opioid is required to stabilize the minor’s acute medical condition, then he/she can prescribe a larger quantity–> doc med condition in the minor’s record and a reason listed why a non-opioid would not be appropriate.
-Another exception would be for the management of pain associated with cancer, palliative or hospice care, or management of chronic pain not associated with cancer.
Emergency Room Prescribing of Opiates PA LAW
-A health care practitioner may not prescribe an opioid to an individual seeking treatment in a ED or urgent care center, or who is in observation status in a hospital, for more
than a 7 days’ supply- No refills
-if provider says its needed or is necessary for the treatment of pain associated with a
cancer diagnosis or for palliative care -then ok. doc the condition and medical records
Opioid Related Continuing Education * PAW LAW*
-requires pharmacists to obtain 2 hours of the 30 hours of required continuing education in the area of pain management, identification of addiction, or prescribing or dispensing of opioids.
-preliminary requirement for those obtaining an initial license to demonstrate
compliance within 12 months of obtaining a license by completing 2 hours of education in pain management or ID of addiction AND 2 hours in prescribing or dispensing of opioids.
