Exam 2 Flashcards
Controlled Substances
How long do DEA registration last for?
36 months/3 years
What is the DEA 224 form?
this applies to pharmacies
-for renewal of the pharmacy
-must be completed at least 60 days before expiration
Marijuana, LSD, heroin, mescaline are what schedule of drug?
C-1
-lack safety
-high potential for abuse
High potential for abuse that are allowed to be used?
C-2 drugs
-pure opiates:
–morphine, hydromorphone, oxcycodone
–methadone, fentanyl, cocaine
What drugs include C-2 drugs but compounded with other ingredients/have smaller dose?
C-3
-Less potential for abuse compared to C-1/C-2
Federal Government vs. NYS - classification of anabolic steroids?
Federal government: C-3
NYS (and other strict states): C-2
Benzodiazepines are classified as what controlled substances?
C-4
-low potential use
-possible limited physical or psychological dependence
Lowest potential for abuse is?
C-5 drugs
-lead to physical or psychological dependence
-pure opiates C-2 + limited quantities C-5
(divisible by 5)
-“exempt narcotics”: Robitussin AC dont need prescriptions
Rank from most to least possibility of substance abuse?
C-1 > C-2 > C-3 > C-4 > C-5
When can manufacturers apply to DEA for exemption of a controlled substance?
-in exempt substances, this can go from controlled substance status to non-controlled if it is UNLIKELY THAT THE PRODUCT WILL BE ABUSED
What is required in order to order and transfer C-1 and C-2 substances?
DEA form 222. this is REQUIRED to returned a C-2 to the supplier
Who is allowed to fill out the DEA 222 form?
only PHARMACISTS with power of attorney can sign
Can any prescriber prescribe controlled substances? If not, who can?
prescriber must be authorized to prescribe controlled substances
-must be registered with the DEA or exempt from registration pursuant to the CSA
What makes a controlled prescription valid?
RX must be issued for LEGITIMATE MEDICAL PURPOSE (proper treatment)
When can we not accept/dispense a controlled substance?
RX may not be issued in order to gain access by the MD for general dispensing to patients
How can MDs give patients controlled substances?
must get the medication directly from the wholesaler or manufacturer (this means they would be responsible and require documentation to prescribe and administer drug)
What are the must have requirements on a controlled substance RX?
-full NAME and ADDRESS of patient
-drug NAME, STRENGTH, and FORM
-QUANTITY
-SIG
-name, address, DEA number of MD
-DATED AND MANUALLY SIGNED ON THE DAY IT WAS WRITTEN (written RX)
-written in INK, INDELIBLE PENCIL, TYPEWRITE (written RX)
What are the NYS specific requirements in regards to e-RXs?
-ELECTRONIC RX required for C-2 products
-some exceptions where they can be paper
If a MD doesn’t have a personal DEA number, can. they still prescribe a controlled substance? If so, when is this allowed?
Yes!
-IF they work for a HOSPITAL, they must use the hospital DEA number and numerical suffix designated to the prescriber (usually residents)
-IF they work for the MILITARY OR PUBLIC HEALTH SERVICE, requirement to provide service identification number
Can all pharmacists fill controlled substances? Why or why not?
yes as long as they are acting in the usual course of his or her professional practice
-pharmacist must be registered with DEA (rare) or employed by a registered pharmacy (pharmacy locations are REQUIRED to have a DEA for that practice)
T/F: Prescribers are required to have a separate DEA registration to dispense AND administer?
False
PRACTITIONERS who dispense and administer are required to have separate DEA registration
if a physician isn’t registered to conduct treatment through prescribing medications, what can they do?
ADMINISTER drugs for acute withdrawal
-requires referral for treatment
-not more than 1 day of medication at a time and not more than 3 days
From a federal standpoint, does buprenorphine (Suboxone) require a special registration?
NOT ANYMORE
However, if the STATES require it or its considered the stricter law in that individual state, then YES, special registration is required.
In regards to ELECTRONIC (E-) controlled RXs, do presribers need to send in e-RXs for controlled substances?
Federally, NO it isn’t required
NYS: REQUIRED (few exceptions)
When receiving an electronic prescription for a controlled RX, are pharmacies required to accept it?
Federally, NO
If a pharmacy is to dispense a controlled substance, how are they able to verify that the prescription is allowed, verified, and not a fraudulent prescription?
through the use of certification of prescribing and dispensing systems
-computer programs are used in the pharmacy (and prescribers) to help detect if the RX is an approved certification body
-system is programed to determine if it is compliant with DEA requirements
how can the system determine and accept if the prescriber and what is being prescribed legal?
DEA requires that there is a “2-factor authentication” in place
-something you know (knowledge), have (hard token stored separately from the computer), are (biometric)
if dispensing a controlled substance without a RX, when is this allowed?
-must not require an RX; no sign of “federal legend”
If dispensing a controlled substance without an RX, how can this be dispensed? is the pharmacist only allowed to do this entire process?
only pharmacist can DISPENSE
but, CASHIER can RING UP at register
dispense < 240ml (48 dose units) of “exempt” opium in any given 48 hours
dispense < 120ml (24 dose units) of “exempt” product (cough syrup with codeine) in any giving 48 hours
A new patient to the area is coming to pick up a controlled substance without a RX. He is 21 years old, but doesn’t have any identification on him, can we dispense it to him?
NO!
yes patient indicates they are over 18 years old, BUT he is unknown to us, thus we don’t know if he really is 21 or over the age of 18.
A regular patient is coming into the pharmacy to pick up a controlled substance without an RX. We know he’s at least 18 years old, but he doesn’t have his identification on him, can we dispense it to him?
Yes.
we know him well, he’s over the age of 18, but he picks up at your pharmacy regularly.
A regular patient is picking up a controlled substance without an RX, what must be done in order to complete this transaction?
have a physical record keeping book OR if digital, scan ID to document all the required details:
-Name and address of purchaser
-name and quantity of the controlled substance
-date they bought it
-name OR initials of dispensing pharmacist
When we are requesting a destruction of controlled substances, is the pharmacy allowed to dispose of them in a medication drop-off box?
NO!
must obtain a DEA 41 form, which they MUST approve of before they can destroy anything
at the pharmacy you work at, they use an authorized distributor to destroy controlled medications. Is the DEA 41 for enough? why or why not?
YES!
BUT we would need to fill out a DEA 222 form if the drugs are specifically C-2!
Some locations have a “Blanket Authorization” to destroy controlled substances. Can they simply destroy them?
They would still need to have a DEA 41 form
the pharmacy you work at doesn’t have a C3-C5 medication a patient is looking for, can you get a transfer of said C-3-C5 from another pharmacy? why or why not?
YES, BUT both the sending and receiving pharmacy must be registered with the DEA, keep detailed records, and as long as no more then 5% of all Controlled substances distributed w/o a wholesaler permit from DEA are transferred out
If a pharmacy is transferring a C-2 to a different pharmacy, what is additionally required to do this?
usual requirement for controlled transfers, BUT require the use of a DEA 222 form to document to the DEA that the medication has been sent to that intended pharmacy
In order to transfer C3-5, _____ must be recorded to be a valid transfer
-Drug name
-dosage form
-strength
-quantity
-date transferred
-name, address, and DEA numbers of both pharmacies
what happens when a pharmacy/company is going out of business?
-must have complete inventory record
-filled out DEA 222 form for any C-2s
-receiving pharmacy must maintain records for 2 years
Medicare vs. Medicaid
Medicare: federal program
medicaid: federal/state program
–varies by state
What is the “Medicare programs and the prescription drug improvement and modernization act (MMA) of 2003?
-regularly revised
-4 programs:
–Part A: Hospital
–Part B: physician + services
–Part C: medicare advantage (managed care)
–Part D: Drugs
How does Prescription Drug Plan (PDP) work?
-Voluntary enrollment
-contract with private insurance
–rx only coverage
–can be part of medicare advantage
-premium and deductible = changes yearly
T/F: Spouses/beneficiaries can utilize the PDP too.
False
spouses/beneficiaries MUST have their own plan
Which tier covers most drugs/least expensive generic drug?
Tier 1
Tier 2 covers _____
preferred BRAND name drugs
T/F: expensive drugs are covered by tier 3 and 4
False
Tier 4 may cover high cost drugs
tier 3 may cover non-preferred brand name drugs
Once a beneficiary is enrolled, what dates can’t the premium and deductible change between?
Jan 1 - Dec 31
When is the only time co-pay’s can change?
if a drug is moved into a different tier
How often can beneficiaries change plans?
once a year
what time range can beneficiaries change their plans?
Nov 15 - Dec 31
When can beneficiaries change plans?
if they move or plan stops service
Under Medicare Part D, what day supply could be allowed to be dispensed by a pharmacy?
90 days
How are Pharmacists paid in regards to Part D?
Providing MTM services to enrolled patients
T/F: Plan sponsors must have MTM programs for patients with chronic multiple conditions.
if true, what type of conditions?
True
asthma, diabetes, hypertension, hyperlipidemia, etc.
Will Part D cover drugs from Canada or other countries?
Yes, but only if HHS certifies that the importation poses NO ADDITIONAL RISK to the public
T/F: “Off label” use of drugs may be acceptable
True
T/F: insurer may change or remove specific drugs from formulary with timely notice
True
What updates were made to the IRA (inflation reduction act) of 2022?
-vaccines = no co-pay
-insulin copay = <$35/month
-expanded subsidies
-elimination of 5% coinsurance for catastrophic phase
-renegotiation of drug price (limited)
What are the 6 drug classes that require most drugs on the formulary?
-anticonvulsants
-antidepressants
-antineoplastics
-antipsychotics
-antiretrovirals
-immunosuppresants
T/F: Med Part D covers research drugs w/o a medically accepted indication.
False
There must be a proper indication in order to be covered, otherwise, not covered
T/F: Categories and classes of drugs can be changed throughout the year.
False
they can only be changed at the beginning of each plan year
EXCEPTION: new drug or new generic or new use
T/F: Appeal processes for drugs that aren’t covered should be available for beneficiaries.
True
What are some groups of drugs not usually covered (rare if it is) under Part D?
-barbiturates
-benzos
-weight loss/gain drugs
-hair growth drugs
-increasing fertility
-RX vitamins (not including Prenatal or fluoride products)
-outpatient drugs that REQUIRE monitoring
When a drug is being removed or moving to a different tier, how long does the notice need to be gicen to CMS?
60 days
T/F: if a patient is using an out-of-network pharmacy, patients pay U&C and submits a form for reimbursement
True
How does the enrollment process work for Med Part D?
initial enrollment period begins the first day of the 3 month before eligibility begins and lasts 7 months (3 months before and 4 months after the month of their birthday)
Are patients allowed to change their plans after enrollment of Med Part D?
NO! they are locked into the plan until next open enrollment
What are the requirements for MTMs?
Part D sponsors must AUTOMATICALLY enroll qualified beneficiaries unless they opt out
beneficiaries = targeted for enrollment at least quarterly
T/F: insurers require more than 3 chronic illnesses and must target at least 5 of 9 core chronic disease states.
False!
-they can’t require more than 3 chronic illnesses
What are the 9 core chronic disease states?
-alzheimer’s
-hypertension
-CHF
-diabetes
-dyslipidemia
-ESRD
-respiratory disease
-bone disease
-mental health
What are minimum intervention requirements of MTM?
–annual comprehensive medication review
-targeted medication review’s should be conducted at least quarterly
-interventions targeted to prescribers can be passive or interactive
-information about save disposal of prescription drugs that are controlled substances, drug take back, in home disposal and cost effective means
What are CSOS electronic order forms?
-electronic orders for C-2’s
-must me maintained electronically for 2 years
-eliminates need for PAPER DEA 222 form
What do CSOS and Public Key Infrastructure (PKI) Technology have to do with each other?
-CSOS utilize PKI to secure electronic transmission
-users required to get CSOS digital certificate for electronic ordering
Who can become a CSOS Coordinator?
-digital certificates -> obtained by authorized personnel/power of attorney
-must be appointed a CSOS coordinator for managing digital certificates
What does the CSOS coordinator do?
Serves as the recognized agent for issues related to digital certificates
How long must the CSOS digital certificate be valid?
Until DEA registration expiration or revocation
How can CSOS certificates be revoked?
under various circumstances
ex: -changes in authorization or compromise
What form is required in order to DESTROY controlled substances?
DEA 41
-Letter to DEA requesting permission
-once each calendar year
-MUST WAIT until DEA says YES
If we are forwarding a drug to an authorized distributor, what is required? Controlled 3-5? Controlled 2?
C3-5: need of DEA 41
C2: also need DEA 222
What are requirements to transfer controlled substances between pharmacies?
-both have DEA registration (required to even CARRY C2-5)
-both must maintain records
-CANT transfer >5% of all controlled substances distributed w/o wholesaler’s permit from DEA
T/F: In order to transfer C-2 drugs, a DEA 222 form is required.
True
Who are considered MIDLEVEL practitioners?
-NP
-Midwives
-PA
-optometrist
T/F: all Mid-level practitioners are allowed to prescribe controlled substances.
False!
Each state has different rules on who is allowed to prescribe CONTROLLED RX
When given a C1-2, what is expected from pharmacists?
must keep C1-2 inventories SEPARATED FROM ALL OTHER RECORDS
-C1 and C2 must also be filed separately
When given a C3-5, what is expected from pharmacists?
-must keep inventories separate/readily retrievable
-RX must be filed separately or readily retrievable
–Red “C” on the lower right hand of RX
–Red “C” not needed if computer assigns separate number system for Controls
How long must inventory or other records be kept?
must be kept and available for at least 2 years from date of inventory
Are C-2 records allowed to be kept with all other records?
No, they must be kept separately, but kept on site of the pharmacy
-only exception is if DEA says otherwise
How often are controlled substance inventory to be taken?
At least every 2 years
Why is a prescribers DEA number important for pharmacist to check?
to ensure that a prescription issued is written by an authorized person
How to verify prescribers DEA number?
Ex: BJ3614511
1st letter:
-B (or also an F): determines if MD, dentists, vets, others.
-M: determines if mid-level practitioner
2 letter:
-First letter of last name
Number:
-add 1st, 3rd, 5th numbers
-add 2nd, 4th, 6th numbers and multiply that by 2
last number must match last number after you add them together
How to read the number:
(3+1+5)+2(6+4+1) = 31
How is prescriber different in hospitals?
-similar to outpatient “MDs”
-MD must be authorized by state
-hospital needs to verify information by state
-hospital has a specific “HOSPITAL” DEA code
Can all mid-level practitioners prescribe medication?
Sorta! check individual state laws
Are pharmacies allowed to keep controlled substances with non-controlled substances?
Yes! only if they are dispersed throughout the shelves to avoid easy determination of what is controlled and not controlled
-electronic alarm system recommended
Who can’t access controlled substance if they work in a pharmacy?
-convicted felons
-anyone who had their DEA registration denied, revoked, or surrendered
Is there any exception to pharmacy employees who can access controlled substances?
-waivers can be requested by DEA and only if the DEA approves
What must a pharmacy do if a controlled substance is stolen?
-Report to DEA diversion field office (phone, fax or written)
-contact local law enforcement authorities
-fill and submit DEA 106
Why was the Combat Methamphetamine Epidemic Act (CMEA) created?
to stop the possible creation of Meth (usually can happen if you add a lot of ephedrine, pseudoephedrine, phenylpropanolamine)
What drugs are considered “scheduled listed products” but nonprescription?
Ephedrine
Pseudoephedrine
Phenylporpanolamine
Who are required to follow the CMEA?
Pharmacies
mobile retail units
What does the CMEA do?
requires that some OTC cold and allergy meds be kept behind the counter
what is the daily and monthly restrictions on ephedrine or pseudoephedrine per individual?
daily: 3.6 g/day
AND
9 grams every 30 days
What is required to purchase ephedrine or pseudoephedrine products? for patients? for retailers?
-purchaser needs to present a photo ID
-retailers must keep information of purchase for 2 years
some states or local laws may add restrictions
What specific record information must be kept on patients who purchase pseudoephedrine products?
-product name
-quantity sold
-name and address of purchaser
-date & time sale
-proof of ID
-signature of purchaser
What is OBRA ‘90?
-Omnibus Budget Reconciliation Act of 1990
-a counseling law
What does Medicaid have to do with OBRA ‘90?
-establishes conditions for the fed. government to reimburse states for outpatient Medicaid services
-in order for a state to get money for the Medicaid program, it must have a DUR program
What is a DUR program?
-Drug Use/Utilization Review program
-must have a retrospective (past drug use) program and prospective (future drug use) program
What is a “Prospective DUR”
-Review of patient’s written medical record and/or his medication profile before dispensing a prescription of the patient
-pharmacist must make a responsible effort to obtain and update a patient medication profile for every person receiving prescriptions
What is required for a patients profile?
-patient name/address/number
-DOB
-sex
-medical concerns
-allergies
-previous medication
-any comments from pharmacists on patient’s drug therapy
T/F: If a patient refuses to give any personal or medical history, the pharmacist must indicate the refusal.
True.
there needs to be detailed documentation
Upon receiving a prescription, how should a prospective DUR be determined?
-Review RX and patient records for over and under utilization of drugs
-therapeutic duplication?
-incorrect dose/dosing regimens
T/F: federal law states how much or what specific information is to be provided by a pharmacist.
False.
There is no law indicating how little or how much information is to be given
If a patient refuses to be counseled, are pharmacists still required to counsel the patient?
No, if a patient refuses to be counseled, a pharmacist doesn’t have to counsel them
What is retrospective DUR?
-not required for individual pharmacies
-done by individual states
-by a committee (healthcare providers)
-review of use of certain drugs over a period of time to ascertain whether appropriate therapy
-may result in recommendation that some prescribing habits of physicians be changed
-may result in board initiated education programs
Are pharmacy interns allowed to counsel?
technically yes, but also is fully up to each state board of pharmacy
What is the basics of law?
Enacted by Congress and signed by President Clinton in 1998
-authorizes the department of health and human services (DHHS) to enact regulations based on the law
What is HIPAA?
-broad and complex law (some that don’t directly impact pharmacy practice)
-main intent of the law is to improve the portability and continuity of health insurance coverage and prohibit discrimination in health coverage
What are the 4 major areas of HIPAA?
-transactions and code sets
-NPI number
-security
-privacy
T/F: every healthcare provider who transmits patient health information electronically is covered under HIPAA (a covered entity)
True
What does PHI stand for?
-Protected Health Information
What are transactions and code sets?
uniform standards in the electronic submission of claims
What is the use of “covered entity”?
to implement policy and procedures that protect information
if a prescriber is covered by HIPAA, what are they required to have?
NPI
What are privacy notices for?
-a notice of privacy practices to be given to each patient first receiving services
-this notice must be signed
What are HIPAA privacy officers responsible for?
for HIPAA training of medical personnel
How long must signed “privacy notice’s” be kept for?
minimum 6 years
Who do patients report HIPAA violations to ?
DHHS office of civil rights
who can sign privacy notices?
-parent/guardian
who is not allowed to sign privacy notices?
-a friend
T/F: patients friends aren’t allowed to pick up prescriptions.
False, they can pick up the prescription (they just can sign a privacy notice)
What is the definition of manufacturing?
production, preparation, propagation, conversion, or processing of a drug/device, either directly/indirectly, by extracting from substances of natural origin or independently by means of chemical/biological synthesis
What is included under “manufacturing”?
-packaging or repackaging
-promotion and marketing of drugs and devices
-preparation and promotion of items for resale in pharmacies and by others
Who is compounding defined by?
-national association of boards of pharmacy (NABP)
-pharmacy compounding accreditation board
-FDA
-Federal law
-US Supreme Court
