Texas MPJE: Dr. C's Review Chapter 2

Schedule I (C-1) Drug Classification

- high potential for abuse and severe potential for dependence

- no currently accepted medical use in treatment in U.S.

- lack of accepted info on safety

- heroin, dihydromorphine, marijuana, LSD, peyote, mescaline, methaqualone

Schedule II (C-II) Drug Classification

- high potential for abuse; may lead to severe dependence

- accepted medical use in treatment (severe restrictions)

- morphine, codeine, dihydrocodeine, oxycodone, APAP w/ hydrocodone (Vicodin), methadone, meperidine, hydromorphone, fentanyl, cocaine, amphetamine, methamphetamine, phenmetrazine, methylphenidate, pentobarbital, secobarbital, amobarbital, glutethimide, phencyclidine

True or False: all controlled substances are narcotics

False - derivatives of opium, poppy straw, cocaine, or ecgonine; all narcotics are controlled substances

True or False: suppository forms of amobarbital, secobarbital, and pentobarbital are Schedule II

False - Schedule III, but other dosage forms are Schedule II

Schedule III (C-III) Drug Classification

- potential for abuse less than C-I & II; abuse may lead to low-moderate physical dependence or high psychological dependence

- codeine + ASA, codeine + APAP (Tylenol #3), chlorphentermine, phendimetrazine, benzphetamine, testosterone, ketamine, paregoric, butalbital + ASA + caffeine (Fiorinal)

Schedule IV (C-IV) Drug Classification

- low potential for abuse; abuse may lead to limited physical or psychological dependence

- dextropropoxyphene, < 1 mg difenoxin, > 25 mcg atropine sulfate per dosage unit, alprazolam, chloral hydrate, diazepam, lorazepam, phenobarbital, diethylpropion, phentermine, carisoprodol, tramadol, pentazocine, butorphanol

Schedule V (C-V) Drug Classification

- low potential for abuse; abuse may lead to limited physical or psychological dependence

- pregabalin (Lyrica), antitussives with codeine, antidiarrheals with opium, brivaracetam (Brivact), lacosamide (Vimpat)

Which entity may manufacturers apply to to exempt a product or chemical from certain provisions of the Controlled Substances Act (labeling, inventory) if the substance is not likely to be abused?

DEA

- substance may be considered controlled for certain criminal violations

What products are exempted prescription drug preparations?

non-narcotic products containing small amounts of phenobarbital, butalbital, chlordiazepoxide, or meprobamate (e.g. Fioricet - butalbital, APAP, caffeine)

Listed Chemicals Definition

chemicals used in manufacturing a controlled substance & OTC products containing pseudoephedrine

- not controlled substances but subject to certain sales limitations and other restrictions

Federal vs. State Scheduling Authority for Controlled Substances

1. Federal - U.S. Attorney General, as head of the Department of Justice, may add, delete, or reschedule substances but must obtain a scientific & medical recommendation from FDA

2. State - Commissioner of Texas Department of State Health Services may add, delete, or reschedule substances but cannot override actions by legislature

True or False: any straight narcotic (i.e. mixed with water or simple syrup), regardless of its concentration, will always be in Schedule II

True

e.g. codeine or opium is only mixed with water or simple syrup

DEA considers compounding of "aqueous or oleaginous solutions or solid dosage forms" with a narcotic ingredient greater than _____% to be manufacturing even if the pharmacist has a prescription to compound the product

20%

Codeine C-V concentration limit

200 mg/100 mL

Robitussin AC and Cheracol contain the max amount of codeine allowed for C-V

Codeine C-III concentration limit

1.8g/100 mL and 90 mg/dosage unit

anything ABOVE this limit = C-II

Way to remember: 9X the limit of C-V (200 X 9 = 1800)

True or False: Texas requires all codeine and dihydrocodeine products to be dispensed pursuant to a prescription

True

Robitussin AC and Cheracol are Schedule V, but require a prescription in Texas

Dihydrocodeine C-V concentration limit

100 mg/100 mL

(half of codeine C-V max)

Dihydrocodeine C-III concentration limit

1.8g/100mL and 90mg/dosage unit (same as codeine)

anything above this limit is C-II

Opium C-V concentration limit

Texas: 50 mg/100mL

(Federal: 100mg/100mL)

Opium C-III concentration limit

500mg/100mL and 25mg/dosage unit

Morphine C-V concentration limit

None listed

- ALL morphine products are either C-II or C-III

Morphine C-III concentration limit

50 mg/100 mL

- the most stringent C-III limit

True or False: a compounded narcotic prescription will never be a Schedule IV

True

What entity must every person or firm that manufactures, distributes, or dispenses any controlled substances or proposes to engage in any of these activities register with?

DEA

True or False: there is a state controlled substance registration in Texas

False

Dispensers (pharmacies and practitioners) register every _____ years with the DEA.

3 years

Practitioner DEA registrations start with what letters?

A, B, F, or G for DoD contractors

What will the second letter of the DEA registration prefix normally be?

first letter of practitioner's last name or the first letter of a pharmacy's or hospital's name

Mid-Level Practitioners definition and DEA number registration

- registration begins with the letter "M"

- practitioners, other than physicians, dentists, veterinarians, or podiatrists, who are licensed, registered, or otherwise authorized under state law to dispense (including prescribing) controls in the course of professional practice

- may include APRNs and PAs if state allows them to prescribe controls; also may include ambulance services, animal shelters, and vet euthanasia techs

Activities requiring separate DEA registrations (C-I - C-V)

manufacturing, distributing, reverse distributing, conducting chemical analysis, conducting research, importing, exporting

Activities requiring separate DEA registrations (C-II - C-V)

dispensing (includes prescribing and administration by practitioners and dispensing by pharmacies) & conducting narcotic treatment program

Verifying a DEA registration number

1. Add 1 + 3 + 5

2. Add (2 + 4 + 6) x2

3. Add the sum of Step 1 + 2 - last digit of sum should correlate to last digit in DEA number

When do individual practitioners, including physicians who register at one location but practice at other locations in the same state, have to register with the DEA at separate locations?

if they maintain a supply of controlled substances at that site or if the site is in another state (not required to register at another site if they only prescribe controls at one location)

True or False: each pharmacy must have a separate DEA registration

True

- sometimes a campus registration may include multiple buildings, but approval for this is done case-by-case

DEA Form 224

Application for new registration for dispensers (practitioners and pharmacies)

- application must be signed by applicant if it is for an individual, by a partner if it is a partnership, or by an officer if it is a corporation

Can a DEA Form 224 applicant authorize another individual to sign the application and renewals?

Yes, by filling out a POA and filing that POA with the DEA registration unit

Who does not have to register with the DEA?

1. An agent or employee of any registered manufacturer, distributor, or dispenser if acting in the usual course of business or employment

-Pharmacists working in a pharmacy

-Nurses working in a hospital or physician's office

2. A common or contract carrier, warehouseman, or employee whose possession is in the usual course of business or employment

3. An ultimate user (patient) who possesses such substance for a lawful purpose

4. Officials of the US Armed Services, Public Health Service or Bureau of Prisons acting in the course of their official duties

In Texas, "federal" practitioners (officials of US Armed Services, Public Health Service, or Bureau of Prisons) do not have to register with the DEA, but can issue _________________ prescriptions. However, they can't issue ______________________________.

1. electronic Schedule II prescriptions

2. written Schedule II prescriptions to be filled off base or out of the facility where they practice when one of the exemptions to electronic controls scripts applies

- this is because they would not be written on a Texas official prescription form & TSBP only issues these to DEA registered practitioners

True or False: when an exemption from electronic prescriptions applies for Schedule III-V controlled substances from federal practitioners in Texas, written prescriptions can be filled off base.

True

Who may administer, dispense, or prescribe controlled substances under the registration of the hospital or other institution when acting in the usual course of business or employment?

Interns, residents, staff physicians, and mid-level practitioners who are agents or employees of a hospital or other institution

- control scripts written by these practitioners are valid and can be filled by any pharmacy, not just the hospital pharmacy where they are employed

What must the hospital assign for each practitioner authorized to use the hospital's DEA number?

a specific internal code that shall be a suffix to the hospital's DEA number (e.g., AP1234563-10 or AP1234563-A12)

- must be available at all times to other registrants and law enforcement agencies

True or False: If the new pharmacy owner has not yet obtained a DEA registration, DEA permits the new owner to continue the business of the pharmacy under the previous owner's registration.

True, provided the following requirements are met:

1. the new owner must expeditiously apply for an appropriate DEA registration and state licensure

2. the previous owner grants a POA to the new owner that provides the following:

- previous owner allows the controlled substance activities of the pharmacy to be carried out under their DEA registration and shall remain in effect for no more than 45 days after the purchase date

- previous owner allows new owner to carry out the controlled substance activities of the pharmacy, including the ordering of controlled substances, as an agent of the previous owner

- previous owner acknowledges, as the registrant, that they will be held accountable for any violations of controlled substance laws which may occur

A pharmacy owner cannot apply for a DEA registration until the owner has received what?

a state pharmacy license and state controlled substance license if applicable

DEA Form 222

ordering schedule II controlled substances

- required for each sale or transfer (except dispensing to ultimate user)

- only one item may be ordered on each numbered line

- the number of lines completed must be noted on the form

- name and address of supplier from whom the controlled substances are being ordered must be entered

- must be signed by the registrant (individual, partner, or officer) and by the person being authorized to execute DEA form 222

- registrant may authorize others to execute forms by creating a POA which doesn't need to be sent to the DEA but must be maintained in the pharmacy

Orders for what substances must have their own DEA form 222?

orders for etorphine hydrochloride and diprenorphine must contain only orders for these substances

Single Copy DEA Form 222

- contain 20 order lines per form

- the purchaser must make a copy of the original form for its records and submit the original form to the supplier (copy may be retained in paper or electronic form)

- electronic copies do not need to be stored on a different server or system from the purchaser's other records; they may also be stored on a system at a location different from the registered location (must be readily retrievable at registered location)

True or False: the supplier may fill an order from a copy of the DEA Form 222

False - may only fill an order from the original form

- supplier must record on the original form the number of containers furnished for each order item and date of products are shipped to the purchaser

True or False: the purchaser should fill out the DEA number of the supplier on the single copy DEA Form 222, but if it is omitted, the supplier may complete that part of the form.

True

True or False: suppliers (e.g., wholesalers) who report transactions to the DEA's Automation of Reports and. Consolidated Orders System (ARCOS) are not required to send a copy of the original DEA Form 222 to the DEA.

True, because this information is already reported to ARCOS

- most suppliers are required to report acquisition and disposition of CIIs and certain CIII-Vs to ARCOS

Who is an example of a supplier who is not required to report transactions to ARCOS?

pharmacy or practitioner acting as a supplier under the 5% rule

- must submit copy of original DEA Form 222 to DEA by mail or email

- pharmacies must have a system to identify any suspicious orders, which, when identified, must be reported online to DEA's Suspicious Orders Report System (SORS)

When a pharmacy acts as a supplier, where must they report to when a suspicious order is identified?

DEA's Suspicious Orders Report System (SORS)

When a product has been received, what must the purchaser report on the copy of the DEA Form 222 it made when ordering the product?

the number of containers received and the date received for each item

Texas rules require a pharmacist to verify that controlled substances listed on the supplier's invoice were actually received by doing what?

recording on the invoice their initials and the actual date of receipt

- the purchaser or person obtaining the product always provides the original DEA Form 222 to the supplier and makes a copy for their records to record the products received

If a completed DEA Form 222 is lost or stolen, what must the purchaser do?

prepare another DEA Form 222 along with a statement containing

- the serial number and date of the lost form

- state that the goods covered by the first order were not received because the form was lost

If a controlled substances order cannot be filled in its entirety, the supplier may fill the order in part and supply the balance within ________ days.

60 days

True or False: a pharmacy may fax a completed DEA Form 222 to a supplier in order for the supplier to prepare and ship the product.

False, the supplier may prepare the order, but the supplier may not ship the product until the original DEA Form 222 is received and verified.

The ____________ allows electronic orders based on digital certificates issued by the DEA Certificate Authority that are valid until the expiration of ________________.

1. Controlled Substance Ordering System (CSOS)

2. the DEA registration for the facility (3 years)

Each pharmacy must appoint a _____________________ who will serve as that pharmacy's recognized agent regarding issues pertaining to issuance of, revocation of, and changes to digital certificates issued under that registrant's DEA registration.

CSOS Coordinator

True or False: CSOS certificates are issued to individual subscribers, even though the certificate expires when the DEA registration of the facility expires.

True

- the certificate must never be used by anyone other than the individual (person, not location) to whom it's issued.

What are the two types of CSOS Certificates?

1. CSOS Administrative Certificate - used to digitally sign communications with the DEA and other participants in the CSOS community; issued only to CSOS coordinators; not valid for electronic ordering

2. CSOS Signing Certificate - used to digitally sign controlled substance orders; issued to approved registrant and POA applicants

*approved CSOS coordinator applicants are only issued a signing certificate if they hold a valid POA for controlled substance ordering and have requested a signing certificate on their CSOS certificate application

When must CSOS applications be audited by an independent third party auditor?

prior to use and whenever changes are made to the software to ensure that the software is in compliance with DEA regulations

An electronic order for controlled substances may not be filled if what occurs?

1. required data fields have not been completed

2. order is not signed using a digital certificate issued by DEA

3. digital certificate has expired or been revoked prior to signature

4. purchaser's public key will not validate the digital certificate

5. validation of the order shows that the order is invalid for any reason

If an electronic order for controlled substances cannot be filled, what must the supplier do?

Notify the purchaser and provide a statement as to the reason

*If a supplier refuses to accept any order for any reason, a statement that the order is not accepted is sufficient.

What must the purchaser do when they receive an unaccepted electronic order for controlled substances from the supplier?

- electronically link the statement of nonacceptance to the original order and the original statement must be retained for 2 years

- must issue a new order for the order to be filled

*neither a purchaser nor supplier may correct a defective order

True or False: CIII-Vs can be ordered through normal ordering processes from a wholesaler or manufacturer.

True

- must be documented by a pharmacy with an invoice provided by the wholesaler or manufacturer

When ordering CIII-Vs, what must the invoice provided by the wholesaler or manufacturer contain?

1. name of controlled substance

2. dosage form and strength

3. number of units per container (e.g., 100 tablet bottle)

4. quantity received (containers)

5. date of receipt

6. name, address, and DEA number of registrant from where controls were received

All invoices for controls must be initialed by the receiving pharmacist in Texas, except in what classes of pharmacies?

Class C-ASC and Class F pharmacies - must be signed by the person receiving who does not have to be a pharmacist

The 5% Rule

- a pharmacy doesn't have to register with the DEA as a distributor as long as total quantities of controls distributed during a calendar year do not exceed 5% of the total quantity of all controls dispensed and distributed during the same calendar year period

* example - if a pharmacy distributes and dispenses a total of 10,000 doses of all controls, then they would be allowed to transfer 500 doses without being registered with DEA as a distributor.

True or False: a DEA Form 222 is required for all controlled substances transfers.

False, only CIIs

- CIII-Vs transfers only require an invoice provided by the supplier

True or False: all controlled substances transfers can only be made to address listed on a DEA registration.

True

True or False: for all controls, an invoice is provided by the supplier or seller to the purchaser.

False

- for CIIs, the purchaser receiving the product initiates and fills out the DEA Form 222, which is sent to the supplier or seller.

Where may pharmacies store controlled substances?

-In a secure locked cabinet

-By dispersal throughout the non-controlled stock to deter theft

Where may pharmacies NOT store all controlled substances?

on one unsecured shelf

In Texas, what controlled substances are required to be kept in locked storage?

CIIs in Class C (institutional) and Class F (freestanding emergency medicine care facility) pharmacies

Theft or significant loss of controlled substances

1. Must be reported in writing to DEA within one business day of discovery (DEA also recommends notifying local police)

2. TSBP requires notification to the Board immediately upon discovery

3. Complete DEA Form 106 online at DEA's website within 45 days of discovery

Reporting Losses of Listed Chemicals (Primarily Pseudoephedrine Products in a Pharmacy)

1. Required to report any unusual or excessive lost, disappearance, or theft of a listed chemical to the DEA at the earliest practicable opportunity

2. A written report must be provided within 15 days and must include description of the loss circumstance (in-transit, theft from premises, etc.)

3. DEA Form 107 is used to report the loss

DEA Convicted Felon Rule

A pharmacy cannot employ someone who has access to controls if the person has been convicted of a felony involving controls UNLESS a waiver is granted by the DEA

DEA Employee Screening Procedures

DEA requires all pharmacies to screen potential employees with specific questions regarding criminal history and use of controls

DEA Employee Responsibility to Report Drug Diversion

Individual employees are required to report any diversion by other employees to a responsible security official of the employer

When could a hospital secure a patient's controlled substances brought from home in their hospital room (e.g., in a small safe or secure lockbox), so that the hospital is not deemed to have taken possession of the controlled substances?

If a patient is admitted to a hospital via ambulance/EMS, there is no family present, the patient has dispensed controlled medications in their possession, and the treating practitioner deems that it is medically appropriate for the patient to continue to take any controls brought to the DEA-registered hospital

it would not be considered an unlawful distribution by the ultimate user (patient)

When can a hospital turn over a patient's medications, including controls, brought from home to a member of the patient's household?

If a patient is admitted to a hospital via ambulance/EMS, they have dispensed medications in their possession, the treating practitioner deems it to be medically inappropriate for the patient to continue taking said medication(s) or it is the hospital's policy not to permit patients to bring already dispensed controls into the hospital, and the member of the patient's household arrives at the hospital.

When may a member of a patient's household dispose of a patient's medications, including controls, brought from home in the hospital's collection receptacle?

If a patient is admitted to a hospital via ambulance/EMS, the treating practitioner deems it to be medically inappropriate for the patient to continue taking said medication(s) or it is the hospital's policy not to permit patients to bring already dispensed controls into the hospital, a member of the patient's household arrives at the hospital, and a hospital has modified its DEA registration to become an authorized collector and has placed a collection receptacle at its registered location.

When may a hospital provide one or more mail-back packages to a member of the patient's household to place the patient's medications, including controls, brought from home into the mail-back package(s) and seal them for mailing to the authorized DEA-registered reverse distributor for disposal purposes?

If a patient is admitted to a hospital via ambulance/EMS, the treating practitioner deems it to be medically inappropriate for the patient to continue taking said medication(s) or it is the hospital's policy not to permit patients to bring already dispensed controls into the hospital, a member of the patient's household arrives at the hospital, and a hospital has empty mail-back packages

no modification of the DEA registration is required

When should affected entities contact local law enforcement or their local DEA Diversion Field Office for guidance on proper medication disposal procedures?

Under circumstances where there is no authorized person to dispose of the controlled substances, such as when controlled substances are abandoned and their return to the ultimate user is not feasible or when there is no member of a patient's household present.

Federal Transfer Warning

Required to be on the label of CII-IVs when dispensed to a patient: "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed."

*exception - controls dispensed in a "blinded" clinical study

*not required on labels for CVs or dangerous drugs (non-controls)

On-site destruction of controlled substances in a pharmacy

DEA Form 41 - requires the name and NDC number of the drug, the strength, dosage form, package size, and quantity destroyed; also requires the recording of the method by which the drugs were destroyed and two signatures of employees who witnessed the destruction

*Form 41 is also used to document destruction of controls that a pharmacy received as an authorized collector, even though these drugs are not "stock" because they are not part of the pharmacy's inventory

Disposal and Destruction of Controlled Substances - Transfer to an Authorized (Registered) Reverse Distributor

Preferred method of destruction; a transfer from one DEA registrant (the pharmacy) to another (the reverse distributor); the transfer must be documented with an invoice for CIII-Vs and a DEA Form 222 for CIIs

*DEA Form 41 is not required

Disposal of controlled substances collected from ultimate users and other non-registrants

- DEA allows pharmacies to modify their DEA registrations to serve as a collector of controls from ultimate users (patients, personal representatives of patients in the event of the patient's death, LTC facilities)

- a pharmacy that serves as a collector must meet specific requirements for collection receptacles and may also provide a mail-back program

- drugs collected in receptacles may either be destroyed on-site or sent to a DEA-registered reverse distributor for destruction

- DEA also conducts Drug Take Back Days

True or False: a pharmacy or hospital is required to serve as a collector of controlled substances from ultimate users and other non-registrants

False

- modified pharmacy DEA registration and must meet specific requirements

DEA Form 41 has a separate section for "collected substances" and instead of indicating the specific controlled substance being destroyed, what is required to be documented?

the unique identification number of the inner liner from the collection receptacle or the mail-back package

True or False: a collector that conducts a mail-back program may only accept packages that the collector made available

True - if the collector receives a package that they did not make available, the collector must notify DEA within 3 business days of receipt

The SUPPORT Act (2018)

A comprehensive opioid bill passed by Congress authorizing employees of a qualified hospice program to handle controlled substances for the purpose of destruction that were lawfully dispensed to a person receiving hospice care

An initial inventory is required how soon after a pharmacy is open for business?

on the first day the pharmacy is open for business

True or False: TSBP rules require a biennial (every 2 years) inventory that must be maintained in the pharmacy for 2 years.

False - pharmacies in Texas must conduct an annual inventory of controlled substances, while DEA federal law only requires biennial inventory

True or False: an exact inventory count is required for CII-CVs

False - exact count required for all CIIs; estimated count allowed for CIII-Vs unless the container holds more than 1000 tablets or capsules

True or False: an estimated count is allowed for CIII-CVs unless the container holds less than 1000 tablets or capsules

False - unless the container holds MORE than 1000 tablets or capsules

In Texas, when are perpetual inventories for controls required to be maintained?

- CIIs in Class C (institutional) pharmacies

- all controls stored at a remote location under the remote pharmacy rules

- all controls in Class C Ambulatory Surgical Centers (ASCs)

- all controls in Class F (freestanding emergency medical facility) pharmacies

TSBP rules require that inventories (other than initial and change of PIC) be signed by who?

person(s) taking the inventory and the PIC

*the signature of the PIC is required to be notarized within 3 days of the day the inventory is completed, excluding Saturdays, Sundays, and federal holidays

Records of controlled substances must be maintained for ____________ under federal and Texas law

2 years

DEA requires that records and inventories of __________ be kept separately from all other records, while records of _____________ must be maintained separately or be "readily retrievable" from other records.

1. CIIs

2. CIII-Vs

*readily retrievable means the record is kept or maintained in such a manner that it can be separated from all other records in a reasonable time or that it is identified by an asterisk, a redline, or some other identifiable manner such that it is easily distinguishable