The Closed System of Controlled Substance Dispensing Flashcards
What does it mean to have a legitimate medical purpose and usual course of professional practice?
Acting in accordance with a standard of medical practice generally recognized and accepted in the United States
What is an example of the Scope of Practice?
Dentists are IPs, however they are not trained in the differential diagnosis of cough and therefore, should not be prescribing for this purpose
What is the meaning of Corresponding Responsibility?
- Pharmacists are legally responsible for the proper dispensing of controlled substances
- Knowingly standard is one of the conscious disregard for the obvious
- When suspicions exist, pharmacist is expected to exercise professional judgement and investigate
Pharmacists will more likely face enforcement action in situations that what?
Where there is blatant or glaring misconduct
What are the Prescriber Red Flags?
- Prescriber is outside pharmacy trade area
- Does not have relationship with patient (no medical evaluation)
- Routinely writes for large quantities of CDS
- Writes the same CDS prescriptions repeatedly
- Always provides the same diagnosis
- Writes outside scope of practice
What are the Patient Red Flags?
- Patient insists on paying cash
- Doctor or pharmacy shopping
- Resides outside the pharmacy trade area
- Asks for controlled substance by the color or manufacturer or street names
- Routinely attempts to get early refills
- Groups arriving together form the same prescriber with the same medications
- Arriving at peak or closing times and asking you to rush
What are the Prescription Red Flags?
- Prescriptions written in dangerous combinations
- Multiple long-acting or short-acting opioids prescribed together
- Written for usually high dose or quantity
An example of prescription red flag of a dangerous combination is what?
Cocktails: opioid, benzo, muscle relaxant
Red Flags are what?
Circumstances surrounding the presentation of a Controlled Substance about the validity of a prescription
What can be an example of Documenting Resolution of Red Flags?
Asking the patient something, something to fall back on
What are ways to Resolve a Red Flag?
- Look at security features of prescription
- Verify DEA number
- Review PMP
- Ask the patient questions
- Contact prescriber
What are Security Features of a controlled substance prescription (written Rx)
- Watermarks: prevent photocopying
- Stamps or Embossing
- Quantity check-off boxes
- Signature line is microtext
- Void is more than one prescription is written per blank
What are the features of a DEA Number?
- Consist of 9 digits
- Typically 2 letters then 7 computer generated numbers
What does the 1st letter indicate in the DEA Number?
A, B, G, and F = dispensers
M = mid-level practitoner
P, R= distributors
What does the 2nd letter indicate in the DEA Number?
First letter of registrant’s last name or first letter of the business name
What are the steps for Verifying a DEA Number?
- 1st + 3rd + 5th
- (2nd + 4th + 6th) x 2
- Sum 1st and 2nd steps
- Last digit from step 3 = last number of DEA number
What are Prescription Monitoring Programs?
State PMPs require pharmacies to electronically transmit to the state a record of CDC prescriptions dispensed
PMPs can catch what?
Excessive quantities that are being follies outside of your pharmacy, assess patient risk, and see where they are filling too soon
PMPs can track what?
Patients, Physicians, and Pharmacies
What are practical considerations with PMPs?
- You must enter at least the first 3 letters of first and last name
- Look at more than just the last fill
- Be sure to look at fill date and NOT written date
- Patients could be under multiple names
What is Refusing to Fill?
- You know that the prescription is invalid
- You believe it is unsafe or could harm the patient
What is Waiting to Fill?
- Resolution of red flags can take time
- Refilling controlled substances excessively early may put patient at risk of harm and pharmacist at risk of litigation
What are the Considerations of Pain & Addiction Treatment?
- Pain vs. Addiction
- Legitimacy
- Clinical Judgment
- Federal/State Efforts Opioid Epidemic
Differentiating treatment of Pain from Addiction is important for what reason?
Determine whether the purpose of opioid treatment is legally for pain or illegally for addiction
It is important to ascertain whether taper-down dosages are to mitigate what?
Withdrawal due to physical dependence, or for detoxification of addiction
Prescriptions filled by a pharmacy should NOT be for what?
Treatment of Addiction, only allowed within OTPs or in concordance with DATA
Legitimacy of Opioid Prescriptions in Pain Treatment is a problem, and therefore pharmacists should what?
Familiarize themselves with the medical standards of practice for diagnosing and treating pain
Clinical Judgment and Pain treatment are concerns but you must remember that what?
- Treatment of pain is a legitimate medical purpose
- Drug tolerance and physical dependence as a consequence of opioid use is normal and natural
Balancing pain treatment in an opioid epidemic is a concern when state regulations are what?
- Limiting prescribing/dispensing of controlled substances for acute pain
- Security prescription blanks, electronic prescribing mandates
What is a CDS Prescription?
An order for medication dispense to or for an ultimate user, does NOT include orders for medication dispensed for immediate admin
Therefore, CDS Prescriptions in terms of hospital orders means what?
A medication order in a hospital is not a prescription
Hospital pharmacists do not have to comply with the same record keeping and labeling requirements
What must be included in the Rx if the IP is exempted from DEA Registration?
- Name of prescriber stamped, typed, or handprinted
- Signature or prescriber
- DEA number of institution and special internal code number
In FEDERAL facilities, the IP will have what instead of a DEA number?
Service Number
In order to prescribe controlled substances IPs must what?
- Be authorized to prescribe in their state
- Be registered by DEA or exempt from registration
Only the IP can authorize controlled dangerous drug prescriptions but employees/agents of the IP can what?
Communicate prescription authorization CIII-V to pharmacist or prepare the prescription for signature of IP
Nurses, office staff, agents, etc. CANNOT have access to what?
Two-Factor authentication of the the IP to SIGN e-prescriptions
In order for a pharmacist to dispense controlled substances they must what?
- Be registered individually or employed by a DEA registered pharmacy
- Be acting in usual course of professional practice
IPs can dispense controlled substances if allowed by what?
State Law
What is REQUIRED for ALL Controlled Substance Prescriptions?
- Full Name and Address of Patient
- Name, Address, and DEA Registration # of Prescriber
- Drug Name, Drug Strength, and Dosage Form
- Quantity or Volume Prescribed
- Directions for Use
- Date of Issuance
What are other Requirements of Written CDC Prescriptions?
- Must be signed on day of issuance
- Written in ink, indelible pencil, or typed and manually signed (when e-prescribing not required by STATE)
- Corresponding liability of pharmacist that a CDS prescription complies with all requirements
Before FILING the CDS Prescription it must contain:
- Written or typed name or initials of the dispensing pharmacist
- Date dispensed and number of units or volume dispensed
Can corrections on a C-II be made by a pharmacist?
DEA allows for corrections provided it is allowed under STATE law
For C-III, C-IV, and CV a pharmacist may what to do for the information?
Pharmacist MAY ADD or CHANGE any information after consultation with practitioner and documentation EXCEPT:
1. Patient Name
2. Controlled Substance Name
3. Prescriber Signature
For dispensing C-II Drugs, what are the concerns?
- C-II must be written and signed by prescriber or signed electronically
- Refills are NOT permitted
- Transfers are NOT permitted
What is an EXCEPTION to dispensing C-II Drugs?
Emergency Situation with ORAL authorization
What is allowed for emergency situations for ORAL authorization of C-IIs?
- Only a NECESSARY quantity for the emergency period (by state)
- Pharmacist must immediately reduce to writing (fax acceptable)
- Reasonable effort to verify it is from a registered individual practitioner
For Emergency ORAL Authorization of C-IIs, what must happen WITHIN 7 DAYS?
Prescriber must deliver a written prescription to pharmacy within 7 DAYS = FEDERAL
The prescriber must deliver a written prescription to the pharmacy after emergent oral authorization of C-II within what time period in Oklahoma?
72 HOURS
What must be on the face of the Rx in emergent oral C-IIs?
Must have “Authorization for Emergency Dispensing” on face of Rx and DATE of the ORAL order
If the prescriber fails to provide prescription within given timeline for emergent oral C-IIs, what must the pharmacist do?
MUST contact DEA
Fax sent by practitioner or agent may serve as the original prescription (emergent C-II) if what?
- Narcotic agent to be compounded for direct administration by injectable route or infusion (IV/IM/SQ/Intraspinal)
- Long-Term Care facility patients
- Hospice patients for C-II drugs
Pharmacies can partially fill C-II CDS up to what?
30 days after the earliest date on which a pharmacy may fill the prescription IF the initial partial fill is requested by the patient or practitioner who issued the prescription
Patients can request more than 1 partial fill, but it must be what?
Filled before 30 day expiration and cannot exceed total quantity written
In LTCFs or for terminally ill patients, you may partially fill up to what?
60 days from date of issuance unless sooner terminated by DC of the prescription
Can you accept multiple C-II Rx for the same drug and patient on the same day?
- Up to 3 prescriptions, not to exceed TOTAL of 90 day supply
- Practitioner must write instructions on 2nd and 3rd prescriptions indicating do NOT FILL until DATE
Multiple C-IIs on the same drug must be supported by pharmacy software meaning?
- Each prescription MUST include both date of issuance and the “do not fill until”, they are SEPARATE prescriptions NOT refills
- CANNOT alter the written date (date of issuance)
The federal multiple C-II prescription regulation does NOT apply to what situations by Oklahoma HB 1446?
- Acute pain immediate release opioid prescriptions
- Major surgical procedure/condined to home status
Acute pain immediate release opioid prescriptions are limited to what?
7 day supply
Major surgical procedure/confined to home status opioid prescriptions are limited to what?
TWO 7-day C-II immediate release opioid prescriptions
When dispensing CIII-V Drugs by federal law, dispensed pursuant to what?
Written, faxed, electronic, or oral prescription (promptly reduced to writing)
Oklahoma does NOT allow routine what?
Oral CIII-V prescriptions
IPs may administer or dispense CIII-V drugs without what?
Prescription
Refilling CIII and CIV prescriptions are limited to what?
6 months after date of issuance or 5x, whichever comes first
May a physician authorize additional refills for CIII-IV prescriptions if the original was written for less than 5 refills?
YES, may only write up to 5 refills and refill quantity CANNOT exceed quantity originally authorized
Is it advisable to refill CDS III-IV prescription with expectation of approval?
NO
For recording refills of CIII and CIV prescriptions, records must be maintained for how long?
2 years = Federal
5 years = State
Partial Filling of CIII-V Prescriptions are permitted if what?
- Recorded in same manner as refill
- Total quantity dispensed does not exceed total prescribed
- No dispensing after 6 months from date of issuance
Why is it important to differentiate partial fills from refills?
Partial fills could result in more than 5 instances of “dispensing” provided other points above are maintained
Partial Fill Does NOT equal what?
does NOT equal refill
CDS prescription information may be transferred once between pharmacies if state law allows, what is Oklahoma law?
The prescription must be filled at least once at original pharmacy prior to transferring
What are the Labeling Requirements for ALL Schedules?
- Pharmacy name and address
- Serial number of the prescription
- Name of the patient
- Name of the prescriber
- Directions for use
- Cautionary statement
What is a cautionary statement for scheduled drugs?
Caution: federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed
For electronic transmission prescriptions the DEA regulations what?
- Security
- Accountability
Prescribers must undergo what for electronic transmission prescriptions?
- Undergo identity proofing in person or remotely
- Digitally sign using 2 or 3 factors for authentication
Agent of prescriber can enter prescription information for approval but cannot have access to authentication factors and sign. What are the possible factors for authentication?
- Something you KNOW, password/pin
- Something you HAVE, cell phone
- Something you ARE, fingerprint
What are pharmacy requirements for electronic transmission prescriptions?
Pharmacist must digitally sign and pharmacy must archive prescription
If prescription transmission fails, regulation establishes requirements must be followed
i.e. print/sign: note it was originally e-prescribed (pharmacy VOIDs one)
Return and Disposal of CDS, Secure and Responsible Drug Disposal Act of 2010 allows for what?
Allows an ultimate user to deliver to another person for disposal
What is the Ryan Haight Act?
- Defines a valid Rx as one that has been issued for a legitimate medical purpose
- Establishes several other requirements with which ONLINE pharmacies must comply
Long Term Care Facilities LTC, do they register with the DEA?
NO
When is partial filling of CII drugs allowed for up to 60 days?
LTC Facilities
DEA permits what practices in LTCs?
- Automated dispensing systems ADS
- Voluntary collection receptacles by registered collectors
What is an ADS in LTCFs?
Mechanical system that stores, packages, counts, labels, and dispenses medications and maintains transaction information
LTCF nurses can be agents of a Prescriber, but can do/must have what?
- Formal, written and witnessed agreement
- Agent can prepare written prescriptions for signature
- Can convey oral prescriptions from practitioner
- NO oral C-II prescriptions, even emergent but can FAX ALL schedules
Do they have controlled substances in an emergency kit at a nursing home?
Yah, sometimes
In record keeping, what 3 Types of Records are involved?
- Inventory
- Drugs Received
- Drugs Dispersed
Records generally must be kept for a minimum of how long?
2 years
Certain records (financial/shipping) may be kept at a central location if notified to the DEA, but records must be able to what?
Delivered to registered location within 2 business days per DEA request
CI and CII records must be maintained how?
Separately from ALL other records
Requires page break between CII and CIII
CIII-V records need NOT to be maintained separately provided that they are what?
Visually distinguishable from other records, but can be maintained with regular prescriptions
Prior to beginning business and subsequently every 2 years, an inventory must be conducted containing a complete and accurate record of all CDS on hand, many states have stricter laws, what is Oklahoma’s?
Annually
Newly scheduled drugs must be inventoried on what?
Date of Scheduling
Inventory records contain what?
Exact count must be made of CI or CII drugs
In Oklahoma, you must have an exact count for what?
ALL CDS Schedules
Inventory Records must include what?
- Name of Substance
- Dosage Form
- Strength
- Number of units of volume in each container
- Number of containers
Acceptable records for Records of Receipt include what?
Invoices for CIII-V and Form 222 for CII
Records of Receipt must contain what?
- Name of the substance
- Dosage form
- Strength of the substance
- Number of dosage units or volume in container
- Number of commercial containers received
- Date of receipt
- Name, address, and registration number of supplier
What are acceptable records of Disperal?
- Prescriptions
- Record Books
- Form 222
- Invoices
- Records of Disposal
- Theft/Loss
Prescriptions may be filed what 2 ways?
- 3 Separate Files CII, CIII-V, legend
- 2 Separate Files CII, Other controls + legend
What is the DEA Form 41 for?
- DOES apply to spillage/fragments that may occur in the pharmacy (disposal/destruction)
- Does NOT apply to CDS collection from ultimate users of LTCFs
When recording theft or loss, what must be done?
- Registrant must notify nearest DEA office within 1 day of discovery of any theft or significant loss of ANY CDS
- Submit DEA Form 106
- Should also notify: police, OBNDD, OK Board of Pharmacy
What is required on an invoice for CIII-V products?
- Name, dosage form, strength
- Number of dosage units or volume per container
- Number of containers distributed
- Date of distribution
- Name, address, registration number of entity to whom distribution occurred
What is required for C-II products ALWAYS?
Form 222
Total number of dosage units distributed to another registrants must not exceed 5% of total units of CDS distributed and dispensed in one year OR the pharmacy will have to what?
Register as a Distributor
Federally C-V products can be sold without a prescription but dispensing can only be done by a pharmacist/inter, what are the 48 hr limits for a purchaser?
- 8 oz or 48 dosage units of an opium containing product
- 4 oz or 24 units of any other CDS
-OK has stricter laws
Medication or chart orders are distinguished from prescriptions and need only contain minimum information necessary to provide an acceptable dispersal record, but when sending a patient home on a medication what happens?
Must send a prescription
DEA Form 222 are required for any distribution of CI or CII drugs and can serve as what?
Record of receipt or Record of dispersal
DEA Form 222 come in Triplicate (prior to 2021), what does each copy mean?
Copy 1: kept by SUPPLIER (single sheet original)
Copy 2: scanned/email to DEA address on the back of form
Copy 3: remains with PURCHASER (copy of original)
DEA Form 222 are Serially numbered and issued with what?
- Name, address, and registration number of registrant
- Authorized activity
- Schedules registrant is authorized to handle
-Cannot change info on them
Registrant may not correct or change any information or errors on the 222 Forms, what do the lines look like?
- 10 numbered lines on each form, only 1 item per line
- Number of last line completed must be noted at bottom of the form
DEA 222 Forms must be sign/dated how?
- Signed/Dated by Authorized Person
- Power of Attorney must be included on the form
Purchaser upon receipt of order, must record what on the 222 Form?
Record number of containers received of each item and date received
For partial order fills by the supplier in terms of 222 Forms, how long do they have to complete the order?
60 days
Executed Form 222s must be maintained separately from all other records and retained for how long?
2 years
Copy 3 is kept-one site at the register location but where are the other copies?
Copy 1 = supplier
Copy 2 = scanned
Power of Attorney POA to sign DEA Form 222, and can you have more than one POA?
YES
How do you gain POA status?
POA must be signed by
1. Registrant
2. Person who to whom the POA is being granted
AKA TWO Witnesses
What is the Controlled Substance Ordering System CSOS?
Only electronic method for ordering CII between manufacturers, distributors, pharmacies, and other DEA authorized entities
CSOS can be used instead of what for CIIs?
DEA Form 222
