Dr. C's MPJE: Chapter 2
How can a DEA registration number be verified?
1. Add the first, third, and fifth digits. 2. Add the second, fourth, and sixth digits and multiply the sum by 2. 3. Add the sum of steps 1 and 2, and the last digit of the sum should correspond to the last digit of the DEA number.
What is the C-III concentration limit of codeine?
1.8 g/ 100 mL and 90 mg/dosage unit Note: Anything above this would be C-II.
What is the C-V concentration limit of opium?
100 mg / 100 mL Note: Anything above this is classified as C-II in FL.
How many patients can a DATA-waived APRN or PA treat after one year?
100 patients
What is the total amount of codeine that can be sold to any one purchaser within a 48 hours time period?
120 mg (120 cc, 4 ounces)
A pharmacy wishing to maintain shipping and financial records at a central location other than the registered location must notify the nearest DEA division field office. Unless denied, the pharmacy may begin maintaining central record __ days after notifying the DEA.
14
What is the daily limit of pseudoephedrine HCl?
146 of the 30 mg tablets 73 of the 60 mg tablets 36 of the 120 mg tablets
How long do pharmacies have to report any unusual or excessive loss or disappearance of a listed chemical to the FDA?
15 days
How long should records of controlled substances be maintained?
2 years
A pharmacy may compound narcotic controlled substances pursuant to a prescription as long as the concentration is not greater than ___. This applies to aqueous or oleaginous solutions or solid oral dosage forms.
20%
What is the C-V concentration limit of codeine?
200 mg/ 100 mL
What is the total amount of opium that can be sold to any one purchaser within a 48 hours time period?
240 mg (240 cc, 8 ounces)
A physician who is no part of a narcotic treatment program may administer (not prescribe) narcotic drugs to an addicted individual for not more than a ___ period until the individual can be enrolled in a narcotic treatment program.
3 day
A prescriber or dispenser, or their designee, who does not consult the PDMP for any reason shall document the reason and shall not prescribe or dispense greater than a ___ day supply of a controlled substance to the patient.
3 day
Under FL law, what is the maximum quantity allowed on an emergency verbal CII prescription?
3 day supply
How long is a CSOS certificate good for?
3 years
What are the two storage options for hard-copy prescriptions?
3-file system: File 1 (CII only), File 2 (CIII-V), File 3 (non-controlled) 2-file system: File 1 (CII only), File 2 (CIII-V, non-controlled); Within this system, controlled substance prescriptions have to be stamped with red ink in the lower right corner of the prescription with a C.
How many patients can a DATA-waived APRN or PA initially treat?
30
Under FL law, verbal prescriptions for CIIIs are limited to how many days supply?
30
FL does not allow a pharmacist to dispense more than a ___ supply for a CIII controlled substance from a verbal prescription.
30 day Note: Authorized refills may be dispensed but each refill may not exceed 30 days supply.
Extensions of time to report the dispensing of a controlled substance may be granted for no more than ___, if approved.
30 days
What is the total amount of ethyl morphine that can be sold to any one purchaser within a 48 hours time period?
30 mg (120 cc, 4 ounces)
How many patients can a DATA-waived physician treat?
30, 100, 275 patients depending on their authorization
How long should original prescription records be kept?
4 years from date of last dispensing
Which dosage strength of methadone is voluntarily limited to hospitals and narcotic treatment clinics only?
40 mg
On-site destruction of controlled substances in a pharmacy must be done using DEA form ___, which requires the name and NDC number of the drug and the strength, dosage form, package size, and quantity of the controlled substances destroyed. It also requires recording the method by which the substances were destroyed and two signatures of employees who witnessed the destruction.
41
What is the C-III concentration limit of opium according to federal law?
500 mg/100 mL and 25 mg/dosage unit
How long do you have to fill a CIII-CV prescription?
6 months
A supplier may provide a partial quantity for the requested amount, but the remaining quantity must be sent within ___ or the order become void.
60 days
What is the total amount of dihydrocodeine that can be sold to any one purchaser within a 48 hours time period?
60 mg (120 cc, 4 ounces)
PAs and APRNs may only prescribe up to a ___ day supply of a CII. There is an exception for psychiatric nurses.
7
Within how many days should an electronic or written copy of the prescription marked 'authorization for emergency dispensing' be furnished?
7 days
Mobile retail vendors are required to place listed chemicals in a locked cabinet. What is the sales limit?
7.5 g of base product per customer per 30 days
A hardcopy printout summary of such records covering the previous 60 days shall be made available within ___ hours of request by any authorized law enforcement personnel.
72
What is the days supply limit when a practitioner issues multiple CII prescriptions on the same day?
90
The DEA permits prescribers to issue multiple CII prescriptions on the same day, authorizing the patient to receive a total of no more than ___ days supply.
90 Note: This only applies when the prescriber is issuing multiple prescriptions for a CII on the same day, with instructions that some of the prescriptions are not to be filled until a later date.
The DEA registration number starts with what letters?
A B F G
What is the Federal Transfer Warning?
A labeling requirement for Schedule II-V controlled substances: " Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed" Note: The only exception would be for a controlled substance dispensed in a blinded study
What is the Convicted Felon Rule?
A pharmacy cannot employ someone who has access to controlled substances if the person has been convicted of a felony involving controlled substances unless a waiver is granted by the DEA
What is the 5% rule?
A pharmacy does not have to register with the DEA as a distributor as long as total quantities of controlled substances distributed during a 12 month period in which the pharmacy is registered do not exceed 5% of the total quantity of all controlled substances dispensed and distributed during that same 12 month period.
Are faxed forms of the DEA form 222 acceptable?
A pharmacy may fax it in order for the supplier to prepare the order; however, the supplier may not ship the product until the original DEA form is received and verified.
Define registrant.
A physician, PA, or APRN who prescribes any controlled substance in Schedules II-IV for the treatment of chronic non-malignant pain.
When might a faxed CII script be valid?
A practitioner prescribing a CII narcotic for a patient undergoing home infusion/IV pain therapy A practitioner prescribing a CII for patients in a LCTF A practitioner prescribing a CII narcotic for a patient in hospice care
List examples of C-III drugs.
ASA with codeine, APAP with codeine; suppository forms of amobarbital, secobarbital, or pentobarbital; stimulants such as chlorphentermine, phenimetrazine, and benzphetamine; anabolic steroids including testosterone; ketamine; paregoric; and Fiorinal, a combination of butalbital, aspirin, and caffeine
When must controlled substance dispensing be reported through the PDMP system?
ASAP, but no later than the close of the next business day after the day the controlled substance is dispensed
Who is considered a midlevel practitioner?
Advanced practice registered nurses and physician assistants if the state allows them to prescribe controlled substances, Ambulance services, animal shelters, and veterinary euthanasia technicians
Who is exempt from reporting to PDMP?
All acts of administration The dispensing of a controlled substance in the healthcare system of the Dept. of Corrections The dispensing of a controlled substance to a person under the age of 16 Pharmacies and registered dispensing practitioners that do not dispense controlled substances in or into this state must submit a Notification of Exemption From Reporting and must renew the exemption every 2 years when renewing their pharmacy permit
Who does not have to register with the DEA?
An agent of employee of any registered manufacturer, distributor, or dispenser if acting in the usual course of business or employment A common or contract carrier or warehouseman or an employee thereof whose possession is in the usual course of business or employment An ultimate user (patient) who possesses such substance for a lawful purpose Officials of the US. Armed Services, Public Health Service, or Bureau of Prisons acting in the course of their official duties.
Who disposes controlled substances of a hospice patient?
An employee of a qualified hospice program
How often should inventory be conducted?
An initial inventory is required on the first day the pharmacy is opened. A controlled substance inventory is required every 2 years (+/- 6 months).
When might the first fill of a CIII-CV be transferred?
An original electronic prescription for a controlled substance (EPCS) may be transferred to another pharmacy if both pharmacies have the capability to forward and receive the EPCS using an electronic sharing program.
Who has the power to add, delete, or reschedule substances?
At the federal level, the US Attorney General can but must obtain a scientific and medical recommendation from FDA. At the state level, the Florida Attorney General has this power under the FLCSA.
What rules apply to the prescribing authority of PAs?
Authority to prescribe controlled substances must be delegated by supervising physician Schedule II controlled substances are limited to a 7 day supply PAs may not prescribe controlled substances in a pain management clinic PAs may not prescribe psychiatric mental health controlled substances for children younger than 18
What rules apply to the prescribing authority of APRNs?
Authority to prescribe controlled substances must be delegated by supervising physician Schedule II controlled substances are limited to a 7 day supply (this does not apply to controlled substances that are psychiatric medication prescribed by psychiatric nurses) May not prescribe controlled substances in a pain management clinic Except for psychiatric nurses, may not prescribe psychiatric mental health controlled substances for children younger than 18
What are the requirements for counterfeit-proof prescription pads?
Background color must be blur or green and resist reproduction Pad or blank must be printed on artificial water-marked paper The pad or blank must resist erasures and alterations The word void or illegal must appear on any photocopy or other reproduction of the pad or blank The prescription must contain specific information, including a unique tracking identification number for each order on the front of the prescription pad or blank
What are the identification requirements when dispensing controlled substances?
Before dispensing, the person acquiring the substance must present a valid photo ID. If they do not have proper ID, the pharmacist may verify the validity of the script and the identify of the patient with the prescriber or his agent. Verification of health plan eligibility through a real time inquiry or adjudication system is considered to be proper ID. Note: This implies that for cash-paying patients, photo ID is required if the person is not known to the pharmacist.
What is methadone used for?
Both for treatment of severe pain and in the detoxification and maintenance of narcotic addicts in registered narcotic treatment plans
On which prescriptions must the Federal Transfer Warning appear in FL?
CII-CV
What are the two types of CSOS certificates?
CSOS Administrative Certificate CSOS Signing Certificate
What are listed chemicals?
Chemicals that, in additional to legitimate uses, are used in manufacturing a controlled substance
What rules apply to authorized collectors?
Collectors may allow patients to deposit controlled substances into collection receptacles at the registered location or at an authorized LTCF The controlled substances may be commingled with non-controlled substances The deposited substances may not be counted, sorted, inventoried, or individually handled. LCTF staff may dispose of a patient's controlled substances into an authorized collection receptacle within 3 business days of drug d/c. Collection receptacles must be in the immediate proximity of where controlled substances are stored. They must be in securely fastened to a permanent structure, locked, and securely constructed with a permanent outer container and a removable inner container. The inner liner must be water proof, tamper evident, removable, and able to be sealed immediately upon removal with no emptying or touching of the contents or ability to view the contents. The inner liner must be removed by or under the supervision of at least 2 employees of the Authorized collector. Sealed liners may not be opened or otherwise penetrated. Collectors can either destroy the collected drugs on site, transfer them to a reverse distributor, or contact the DEA special agent in charge for assistance.
Which forms must be kept at the pharmacy even if central recordkeeping is permitted?
Completed DEA forms , prescriptions, inventories Note: Unused DEA Form 222s may be kept at a central location, but once they have been executed, they must be kept at the pharmacy.
What must a prescriber do when they prescribe a CII for the treatment of pain related to a traumatic injury with a severity score of 9 or reater?
Concurrently prescribe an emergency opioid antagonist
What are the requirements when destroying controlled substances within a nursing home?
Controlled substances may be destroyed with documentation showing the name, quantity, strength, and dosage form of the drug, the patient's name, the prescription number, and the name of the institution. It must be witnessed by two of the following: consultant pharmacist, director of nursing, facility administrator, a licensed physician/mid level practitioner/nurse/another pharmacist, a sworn law enforcement officer The consultant pharmacist must review all controlled substance destruction documentation monthly to ensure compliance
Where does each copy of the triplicate DEA form 222 go?
Copy 1 (brown) and copy 2 (green) go to the supplier and may not be separated. Purchaser retains Copy 3 (blue) for their records. Supplier indicates the number of packages shipped and date shipped on each line, sends copy 2 to the DEA and retains copy 1 for their records. Upon receipt of the product, the purchaser records on the retained copy 3, the number of packages received and the date received for each line. Once the order is complete, copy 3 should be filed separately or attached to any schedule II invoices that were received.
According to FL law, who must be notified of theft or significant loss of controlled substances?
DEA (federal law) County sheriff within 24 hours of discovery PDM must also notify the FL BOP within 1 business day
What form is used to register with the DEA in order to dispense controlled substances?
DEA Form 224 for registration (first-time) DEA Form 224a for registration renewal
Which form must be completed in the case of theft or significant loss of controlled substances?
DEA form 106
What form is required when sending controlled substances to a reverse distributor for destruction?
DEA form 222
What is the record of receipt for CIIs?
DEA form 222
Which form is required for each sale or transfer of CII drugs (except dispensing to the ultimate user)?
DEA form 222
Transfer of a CII requires ___.
DEA form 222 by the purchaser
Where are CII records keot?
DEA requires that records and inventories of CII controlled substances be kept separately from all other records. Records and inventories of CIII-V controlled substances must be maintained separately or be readily retrievable from other records.
Most suppliers are required to report the acquisition and disposition of C-II and certain C-III and C-IV medications to ____.
DEA's ARCOS Note: If the supplier does not have to do this, they must submit a copy of the original DEA form 222 to DEA either by mail or email.
List examples of C-IV drugs.
Dextropropoxyphene and products with not more than 1 mg of difenoxin and not less than 25 mcgs of atropine stulfate per dosage unit; depressants such as alprazolam, chloral hydrate, diazepam, lorazepam, and phenobarbital; stimulants such as diethylpropion and phentermine; and other drugs such as carisoprodol, tramadol, pentazocine, and butorphanol
Products containing a listed chemical are subject to the which requirements?
Display restrictions: although the products may be sold at any retailer, covered products must be sold BTC, or if on the sales floor, in a locked cabinet Retail Sales Limits: sales of covered products to an individual are limited to 3.6 g of the base product per day and 9 g of the base product per 30 days Product packaging: covered products must be in either blister or unit dose packaging
How long do pharmacies have to fill out DEA form 106?
Does not need to be filled out immediately if an investigation needs to be conducted, but an initial notification must be provided in writing to the DEA within 1 business day of discovery
What components of a CII prescription can pharmacists change?
Drug strength, dosage form, quantity, directions for use Note: This is provided that the pharmacist contacts the prescribing practitioner and receives verbal permission for the change and documents it on the prescription with the name/initials of the individual granting the authorization and the pharmacist.
There is a mandatory 2 hour CE on validation and counseling of prescriptions for controlled substances and opioids. What must this CE include?
Ensuring access to controlled substances for all patients with a valid prescription Use of the PDMP Assessment of prescriptions for appropriate therapeutic value Detection of prescriptions not based on a legitimate medical purpose The laws and rules related to the prescribing and dispensing of controlled substances Proper patient storage and disposal of controlled substances Protocols for addressing and resolving problems recognized during the DUR Education on the provision of a Florida Statute on Emergency Treatment for Suspected Opioid Overdoses and on the State Surgeon General's Statewide Standing Order for Naloxone for as long as the Order is valid and effective Pharmacist initiated counseling of patients with opioid prescription Available treatment resources for opioid physical dependence, addiction, misuse, or abuse
Every person or firm that manufacturers, distributes, or dispenses any controlled substances or proposes to engage in any of these activities must register with DEA. How often fo the dispensers have to register with the DEA?
Every 3 years
List the exempted prescription drug products.
Exempted prescription drug preparations include non-narcotic products containing small amounts of phenobarbital, butalbital, chlordiazepoxide, and meprobamate, Fioricet
When is accessing and consulting the PDMP not required?
For patients under 16 yoa When prescribing or dispensing of a controlled substance to a patient who has been admitted to hospice For non-narcotics schedule V: pregabalin (Lyrica), brivaracetam (Brivact), lacosamide (Vimpat), ezogabine (Potiga) When the system is nonoperational as determined by the FL DOH When the system cannot be accessed because of a temporary technological or electrical failure
What is the 60 day rule with regards to the partial dispensing of a CII?
For terminally ill and LTCF patients, both federal and FL law allow partial fills of a CII as many times as needed as long as the partial fillings are recorded on the script or maintained in the pharmacy's computer system. All partial fills for the terminally ill and LTCF patients must be completed within 60 days.
In FL, suppository forms of amobarbital, secobarbital, and pentobarbital are C-___.
II
An exact count is required for all C-___. An estimated account is allowed for C-___ unless the container holds more than 1,000 tablets or capsules.
IIs III-V
What is the duty to report?
If a pharmacist has reason to believe that a prescriber is involved in the diversion of controlled substances, the pharmacist shall report such prescriber to the FL DOH.
What is the 72 hour rule with regards to the partial dispensing of a CII?
If a pharmacist is unable to fill the entire quantity on a CII prescription, a partial quantity may be provided so long as the remaining quantity is provided within 72 hours. If the remaining quantity cannot be provided, the pharmacist must notify the prescriber.
Why might a pharmacy request an exemption from the electronic record keeping system?
If it maintains a sales volume of less than 72 g of base product in a 30 day period
Why might an individual practitioner have to register for additional DEA numbers?
If they practice at different sites, where they maintain a supply of controlled substances.
The retailer must maintain an electronic or written logbook that identifies the products by name, quantity sold, names and addresses of purchasers, and dates of times of sales of the listed chemicals. What is the exception?
Individual sales of a single convenience package of less than 60 mg of pseudoephedrine
What should the summary record include?
Information to be able to determine the quantity and identity of controlled substances being dispensed under the prescription of a specific prescriber, and the quantity and identify of controlled substances being dispensed to a specific patient.
What if dispensing information was submitted to the PDMP incorrectly?
Information with errors or omissions shall be corrected and resubmitted by the reporting dispenser within 1 business day of receiving notice of the error
Before refusing to fill a prescription based solely on concerns about the validity of the prescription, what must the pharmacist do?
Initiate communication with the patient to acquire relevant information Initiate communication with the prescriber to acquire relevant information In lieu of 1 or 2, but not both, the pharmacist may elect to access the PDMP to acquire relevant information
Who gets CSOS Signing Certificates?
Issued to approved registrants and POA applicants
What occurred as a result of the Drug Addiction Treatment Act (DATA) of 2000?
It allows office-based, specially trained practitioners to prescribe certain narcotic CIII-V drugs to treat opiate dependence through a risk management program outside of a narcotic treatment facility.
For midlevel practitioner's, what does the registration number begin with?
M
What are the mail service limitations regarding listed chemicals?
Mail service companies must confirm the identity of the purchaser. Sales are limited to 7.5 g per 30 day period
Which C-V products are available without a prescription?
Mainly cough suppressant products containing small amounts of codeine, like Robitussin AC, and products for diarrhea containing small amounts of opium.
If a pharmacy does not want to hard-copy print each day's controlled substance prescription refills and sign them for accuracy, what can they do?
Maintain a bound logbook or a separate file in which each pharmacist involved in the day's dispensing signs a statement verifying that the refill information entered into the computer that day has been reviewed by him/her and is correct as shown. Note: For hard-copy print out method, the daily printout must be printed within 72 hours of the date refills were dispensed.
Which activities require separate DEA registration?
Manufacturing (CI-CV) Distributing (CI-CV) Reverse distributing (CI-CV) Dispensing (CII-CV) Conducting research (CI) Conducting research (CII-CV) Conducting narcotic treatment program (CII-CV) Conducting chemical analysis (CI-CV) Exporting (CI-CV)
How many times may CII-IV prescriptions be refilled?
May be refilled as indicated on the original prescription up to 5 times or 6 months.
Who is authorized to prescribe controlled substances (with a valid DEA registration number)?
Medical doctors (MD) Osteopathic physicians (DO) Dentists (DDS or DMD) Podiatrists (DPM) Veterinarians (DVM) Certified Optometrists (OD) Physician Assistants (PA) APRN Psychiatric Nurses
What are the changes regarding DEA form 222?
Moving to a single copy from a triplicate form The new single forms contain 20 order lines per form rather than 10. The purchaser filing out his new form must make a copy of the original form for its records and submit the original form to the supplier. The copy may be retained in paper or electronic form.
What are the requirements for purchasing a listed chemical?
Must be at least 18 years of age Must use the FL Department of Law Enforcement electronic record keeping system to meet the record keeping requirements. Note: This system provides real time tracking of non-prescription sales of these products.
What are the prescription requirements for written controlled substance prescriptions?
Must be manually signed by the doctor and dated Must be written on counterfeit-proof prescription pads obtained from a vendor approved by the FL DOH (does not apply to veterinary prescriptions)
Define emergency opioid antagonist.
Naloxone HCl or any similar acting drug that blocks the effects of opioids; that is administered outside the body; and that is approved by the FDA for the treatment of opioid overdose.
What are the components of a CII prescription that pharmacists cannot change?
Name of the patient Name of the drug Name of the prescribing physician
What information is reported to the PDMP by the pharmacy?
Name of the prescribing practitioner Prescriber's DEA number Prescriber's NPI number Date prescription was issued Date prescription was filled Method of payment Name, address, telephone number, and DOB of person for whom the prescription was written Name, NDC, quantity, and strength of the controlled substance dispensed Name, DEA number, pharmacy permit number, and address of pharmacy Whether prescription was an initial or refill and the number of refills ordered Name of the individual picking up the controlled substance prescription and the type of ID provided
Can CII prescriptions be refilled?
No
Can a pharmacist fill a prescription for a controlled substance if the prescriber is from out of the country?
No
Do chiropractors have prescriptive authority?
No
Do naturopaths have prescriptive authority?
No
Is Fioricet controlled?
No
Can you accept a verbal CII prescription?
No, unless it is an emergency.
Designated agents can communicate a prescription for a CIII-CV controlled substance but cannot authorize or prescribe. Can they communicate a CII prescription?
No. An authorized agent of the prescriber may not verbally communicate an emergency CII prescription to a pharmacist. This task cannot be delegated.
Can a CIII-CV prescription be transferred?
No. Only refills may be transferred.
Does law enforcement have direct access to the PDMP?
No. They may request that information from the PDMP for an active investigation from the DOH if they have entered into a user agreement with the department.
For the treatment of pain other than acute pain, a prescriber must write ___ on a prescription for an opioid listed in CII.
Non-acute pain
What rules apply to the prescribing authority of psychiatric nurses?
Not subject to the 7 day limitation for Schedule II controlled substances if the CII controlled substances are psychiatric medications May prescribe psychiatric controlled substances to children younger than 18
Give an example of a listed chemical.
OTC products containing ephedrine, pseudoephedrine, or phenylpropanolamine
How many times can refills of CIII-CVs be transferred?
Once Note: If pharmacies share an electronic, real-time, online database of prescriptions, they may transfer up to the maximum amount of refills permitted by law and the prescriber's authorization.
Who can dispense CII or CIII controlled substance prescriptions?
Only community pharmacies
What are some rules when filling out DEA form 222?
Only one item may be ordered on each numbered line Orders for etorphine hydrochloride and diprenorphine must contain only orders for these substances 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 or the person authorized to execute DEA form 222 Forms that are no complete, legible, properly prepared, or signed will not be accepted Forms that show any alteration, erasure, or changes will not be accepted
List examples of C-1 drugs.
Opiates and derivatives such as heroin and dihydromorphine; hallucinogens such as marijuana, lysergic acid diethylamide (LSD), peyote, and mescaline; and depressants such as methaqualone
List examples of C-II drugs.
Opium and other narcotics such as morphine, codeine, dihydrocodeine, oxycodone, APAP with hydrocodone, methadone, meperidine, hydromorphone, fentanyl, and cocaine; Stimulants such as amphetamine, methamphetamine, phenmetrazine, and methylphenidate; and Depressants such as pentobarbital, secobarbital, amobarbital, glutethimide, and phencyclidine
Who has to sign DEA form 41?
PDM or consultant pharmacist of record + DEA agent or Dept of health inspector OR PDM or consultant pharmacist of record + medical director or his physician designee or the director of nursing or her nursing designee or a sworn law enforcement officer Note: Nursing homes are exceptions.
What are the requirements for a mail-back collection program?
Packages must be nondescript and shall not have any markings or other information that might indicate it contains controlled substances; be water-proof, tamper-evident, tear-resistant, and sealable; be pre-addressed with and delivered to the collector's registered address; include prepaid shipping costs; have a unique identification number to enable tracking; and include instructions for the user.
Define chronic nonmalignant pain.
Pain unrelated to cancer that persists beyond the usual course of disease or the injury that is the cause of the pain, or more than 90 days after surgery.
Where might controlled be stored in the pharmacy?
Pharmacies may store controlled substances in a secure cabinet that is locked or by dispersal throughout the non-controlled stock to deter theft. Note: They may NOT store all controlled substances on one secured shelf.
Who can reduce an emergency verbal CII prescription to writing?
Pharmacist
Who is required to use the PDMP?
Pharmacists, prescribers, and dispensers, or their designees are required to access and consult the PDMP to review a patient's controlled substance dispensing history each time a controlled substance is prescribed or dispensed.
List examples of C-V drugs.
Pregabalin (Lyrica), antitussive products containing codeine, and antidiarrheal products containing opium
When printing out a refill-by-refill audit trailer for a controlled substance, what must be included?
Prescriber's name Patient's name and address Quantity and date dispensed on each refill Name or identification code of the dispensing pharmacist Original prescription number
Can a pharmacist fill a prescription for a non-controlled substance if the prescriber is from out of the country?
Probably not
What happens if a DEA form 222 is lost or stolen?
Purchaser must prepare another DEA form 222 along with a statement containing the serial number and date of the lost form and stating that the goods covered by the first order were not received because the form was lost.
List the schedules in order of decreasing risk of abuse and addiction.
Schedule I Schedule II Schedule III Schedule IV Schedule V
Which class of drugs is described below? High potential for abuse and severe potential for dependence (addiction); No currently accepted medical use in treatment in the US
Schedule I (C1) drugs
What schedule is the following example? Any prescription for a narcotic that is not mixed with another drug, regardless of concentration
Schedule II
Which class of drugs is described below? High potential for abuse; Have currently accepted medical use in treatment in the US or currently accepted medical use with severe restrictions; Abuse of the drug or other substance may lead to severe physical or psychological dependence (addiction)
Schedule II (C-II) Drugs
Which class of drugs is described below? Have currently accepted medical use in treatment in the US; Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence
Schedule III (C-III) Drugs
Which class of drugs is described below? Have currently accepted medical use in treatment in the US; Abuse may lead to limited physical or psychological dependence (addiction)
Schedule IV (C-IV) Drugs
In FL, what schedule is Epidiolex?
Schedule V Note: Under federal law, it is not a controlled substance.
Which class of drugs is described below? Low potential for abuse; Have currently accepted medical use in treatment in the US; Abuse of the drug or other substance may lead to limited physical or psychological dependence
Schedule V (C-V) Drugs
Where does the DEA Form 41 go?
Sent to the closest DEA office within one business day of destruction
Narcotic treatment facilities may administer and dispense (but not prescribe) narcotic drugs to a narcotic dependent person for detoxification or maintenance treatment. What is considered short term detox? long term detox?
Short term detox means dispensing of a narcotic drug in decreasing doses for a period not to exceed 30 days. Long term detox means dispensing of a narcotic drug to a narcotic dependent person in decreasing doses in excess of 30 days, but not in excess of 180 days.
Who issued a statewide naloxone standing order for all pharmacies in FL that authorizes the dispensing of naloxone to emergency responders?
State Surgeon General Note: Pharmacies would need to have a separate standing order from a physician in order to dispense naloxone to patients, caregivers, or others.
Which drugs may be dispensed through a medication assisted treatment program for opiate dependence?
Subutex (buprenorphine) Suboxone (buprenorphine/naloxone)
What is the record of receipt for CIII-V?
Supplier's invoice
___ was passed by Congress to further control the sale of OTC products containing precursor chemicals used in the illicit manufacturing of methamphetamine.
The Combat Methamphetamine Epidemic Act of 2005
What is E-FORSCE?
The Electronic Online Reporting of Controlled Substances Evaluation program is Florida's prescription drug monitoring program. It is run by the FL DOH.
Who is required to sign the DEA form 224 for DEA registration?
The applicant if for an individual A partner if for a partnership An officer is for a corporation Note: An applicant can authorize another individual to sign the application and renewals by filling out a Power of Attorney. This power of attorney must be filed with the DEA.
What is the second letter of the DEA registration nnumber?
The first letter of the practitioner's last name for individual practitioners or the first letter of a pharmacy's or hospital's name
What must be contained within a written controlled substance prescription?
The full name and address of the patient The drug name, strength, and dosage form The quantity prescribed (numerically and textually) Directions for use Number of refills authorized, if any (not for CII) The name, address, and DEA number of the practitioner If written for another date: the earliest date on which a pharmacy may fill a prescription Must also have a prescription number, the initials of the pharmacist filling the prescription, and the date filled (according to FL law)
Interns, residents, staff physicians, and mid-level practitioners who are employed by a hospital or other institution may use that hospital's DEA number. However:
The hospital must assign a specific internal code for each practitioner authorized to use the hospital's DEA number and this must be available at all times to other registrants and law enforcement agencies. This internal code shall be a suffix to the hospital's DEA number.
What occurred as a result of the Combat Methamphetamine Epidemic Act of 2005?
The law classifies all products containing ephedrine, pseudoephedrine, and phenylpropanolamine as listed chemical products.
What must the invoice when ordering Schedule III-V controlled substances contain?
The name of the controlled subsrtance Dosage form and strength Number of units per container Quantity received Date of Receipt Name, address, and DEA number of the registrant from where the controlled substance was received
When selling a pharmacy, if the new 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, provided the following requirements are met:
The new owner must apply for DEA registration and state licensure ASAP The previous owner grants a POA to the new owner that provides for the following: the previous owner agrees to allow the controlled substance activities of the pharmacy to be carries out under his DEA registration, the previous owner agrees to allow the new owner to carry out the controlled substance activities of the pharmacy, the previous owner acknowledges that he will be held accountable for any violations of controlled substance laws that may occur, the previous owner agrees that the controlled substance activities of the pharmacy may be carries out under his DEA registration and shall remain in effect for no more than 45 days after the purchase date
Define acute pain.
The normal, predicted, physiological, and time-limited response to an adverse chemical, thermal, or mechanical stimulus associated with surgery, trauma, or acute illness. This does not include pain related to cancer, a terminal condition, palliative care, or a traumatic injury with a severity score of 9 or more.
What happens if the written or electronic prescription for an emergency verbal CII prescription is never received?
The pharmacist must notify the nearest DEA office.
What happens if a pharmacist encounters a fraudulent prescription?
The pharmacist must report to the sheriff or other chief law enforcement agency of the county where the pharmacy is within 24 hours or at the close of the next business day, whichever is later.
When are electronic prescriptions not required?
The practitioner and dispenser are the same entity The prescription cannot be transmitted electronically The practitioner has been issued a waiver by the department, not to exceed 1 year The practitioner reasonably determines that it would be impractical for the patient in question to obtain the drug by e-script in a timely manner The practitioner is prescribing a drug under a research protocol The prescription is for a drug for which the FDA requires the prescription to contain elements that may not be included in the e-script The prescription is issued to an individual receiving hospice care or who is a resident of a nursing home The practitioner determines that is in the best interest of the patient or the patient determines that it is in his best interest to compare prescription drug prices among area pharmacies
For the treatment of acute pain, a prescription for an opioid drug listed in CII may not exceed a 3 day supply. However, in some cases a 7-day supply is valid. When does this occur?
The prescriber believes that more than a 3 day supply of such an opioid is medically necessary to treat the patient's pain The prescriber indicates 'acute pain exception' on the prescription The prescriber adequately documents in the patient's medical records the acute medical condition and lack of alternative treatment options that justify deviation from the 3 day supply limit Note: This does not apply to all CII drugs, nor does it apply to all opioids being prescribed for acute pain.
What must the purchaser do if the electronic order is denied by the supplier?
The purchaser must electronically link the statement of nonacceptance to the original order. The original statement must be retained for 2 years.
Why might an electronic order for controlled substances be denied?
The required data fields have not been completed The order is not signed using a digital certificate issued by the 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
What must the supplier record on the DEA form 222>
Their DEA registration number, the number of containers furnished for each ordered item, and the date the products are shipped to the purchaser.
Who gets CSOS Administrative Certificates?
They are issued only to CSOS coordinators and are not valid for electronic ordering.
What rules apply to the prescribing authority of telehealth providers?
They may not prescribe controlled substances unless it is for the treatment of a psychiatric disorder, inpatient treatment at a hospital, treatment of a patient receiving hospice care, or the treatment of a resident of a nursing home facility.
What must the purchaser document on the DEA form 222 once the order is received?
They must record the number of containers received and the date for each item on the copy of the DEA form 222.
Define non-retrievable.
To permanently alter any controlled substance's physical and/or chemical condition or state through irreversible means in order to render the controlled substance unavailable and unusable for all practical purposes
What is the purpose of the PDMP?
To provide the information that will be collected in the database to healthcare practitioners to guide their decisions in prescribing and dispensing these highly abused prescription drugs
What controlled substances can an optometrist prescribe?
Tramadol APAP with codeine (Tylenol 3)
What is the preferred method of destruction of controlled substance inventory in a pharmacy?
Transfer to a registered reverse distributor
t/f: A bound record book must be maintained by the pharmacist that contains the name and address of the purchaser, the name and quantity of the substance, the date of the purchase, and the name or initials of the pharmacist who dispensed the product to the purchaser.
True
t/f: A collector that conducts a mail back program may only accept packages that the collector made available. If the collector receives a package that it did not make available, the collector must notify DEA within 3 business days.
True
t/f: A compounded narcotic prescription will never be C-IV.
True
t/f: A dispenser that has no dispensing transactions to report for the preceding business day must submit a zero activity report.
True
t/f: A hospital that is not part of a narcotic treatment program may administer narcotics to a drug-dependent person for either detoxification or maintenance therapy if the patient is being treated in a hospital for a condition other than addiction.
True
t/f: A prescription for a controlled substance may not be issued on the same prescription blank with a prescription for a non-controlled drug.
True
t/f: A registrant may authorize other individuals to execute forms by creating a POA. This POA does not need to be sent to the DEA but must be maintained in the pharmacy.
True
t/f: CSOS certificates must never be used by anyone other than the individual subscriber (a person, not a location) the certificate was issued to.
True
t/f: FL's PDMP is part of NABP's PMP InterConnect, allowing pharmacists to perform queries of a patient's controlled substance use in most other states.
True
t/f: Florida passed legislation in 2019 requiring that healthcare practitioners issue all prescriptions (including controlled prescriptions electronically.
True
t/f: Military and federal practitioners are exempt from having to register with the DEA.
True
t/f: Newly scheduled drugs or drugs moved from one schedule to another must be inventoried on the day scheduled or moved to a new schedule.
True
t/f: PDMP data is confidential and considered PHI.
True
t/f: Separate registration is required for separate locations.
True
t/f: The Public Health Act permits a FL-licensed pharmacist to dispense an emergency opioid antagonist such as naloxone based on a non-patient specific standing order for an auto-injection delivery system or intranasal application delivery system.
True
t/f: The narcotic substance must be compounded with one or more non-narcotic therapeutic ingredients.
True
t/f: Under FL law, all prescriptions must be filled within one year after the date issued or the first date authorized to fill.
True
t/f: When dispensing CIII-CVs, the purchaser must be at least 18 years of age.
True
t/f: You need a photo ID to purchase products containing listed chemicals.
True
t/f: In an emergency situation, a practitioner may provide a verbal CII prescription to a pharmacy.
True Note: This communication must be from the prescriber. An emergency means that the immediate administration of the drug is necessary for the proper treatment of the ultimate user, that no alternative is available, and that it is not possible for the prescriber to provide a written prescription.
What is the 30 day rule with regards to the partial dispensing of a CII?
Under the Comprehensive Addiction and Recovery Act (CARA) of 2016, federal law was modified to allow partial fills of a CII for up to 30 days if requested by the patient of the prescriber. The total quantity dispensed may not exceed the original amount prescribed. This applies to written and electronic prescriptions, but not to emergency verbal CII scripts.
What is the CSOS Signing Certificate used for?
Used for digitally signing controlled substance orders
What is CSOS Administrate Certificate for?
Used to digitally sign communications with the DEA as well as with other participants in the CSOS community
What does it mean to validate a prescription?
Validating a prescriptions means the process implemented by the pharmacist to determine that the prescription was issued for a legitimate medical purpose. Note: If the pharmacist determines that, in his or her professional judgement, any concerns with the validity of the prescription cannot be resolved, the pharmacist shall refuse to fill or dispense the prescription.
Is marijuana legal in FL?
While FL and many other states have legalized the medical or recreational use of marijuana, it is still a C-1 drug and under federal law, it is technically illegal.
How long do you have to report a theft or significant loss of controlled substances to the DEA?
Within one business day
A DATA waived practitioner (provided by SAMHSA) is provided a ___ code that must be included with the prescriber's DEA number.
X
Can a pharmacist write 'acute pain exception' or 'non acute pain' if verified with the prescriber?
Yes
Do prescribers need to write the words non-acute pain on a prescription for an opioid drug listed in CII if the quantity is greater than a 7 day supply?
Yes
Is a prescription from a telehealth provider valid?
Yes, assuming they have a valid practitioner-patient relationship.
Can you accept faxed CIII-V prescriptions?
Yes, but they must have the prescriber's original signature. Electronic signatures are not valid.
Can a pharmacist fill a prescription for a controlled substance if the prescriber is from out of state?
Yes. They may fill the prescription if the pharmacist validates the prescription and it is for a chronic or recurring condition.
While any pharmacy can stock methadone, it can only legally be dispensed as ___.
an analgesic for pain treatment
Transfer of CIII-V requires ___.
an invoice provided by the supplier
Methadone cannot be dispensed for the maintenance or detoxification of addicts unless it is provided through a ___.
registered narcotic treatment center
How can CII substances be electronically ordered?
via Controlled Substances Ordering System (CSOS)
Can you accept a verbal CIII-V prescription?
yes
