Juris Exam 2

Comprehensive Drug Abuse Prevention and Control Act of 1970 **(CSA)**

* The Controlled Substances Act (CSA) was passed by Congress as Title II of the Comprehensive Drug Abuse Prevention and Control Act of 1970. And signed into law by President Richard Nixon on October 27, 1970.
* The CSA creates a **closed system of distribution.**
* Subchapter 1 -- provides guidance on control and enforcement of controlled substances
* Part C of Sub 1 -- is guidance for Manufacturers, Distributors and Dispensers
* Subchapter 2 -- provides guidance on Importation and exportation of controlled substances

Drug Enforcement Administration (DEA)  

* DEA responsible for all parts of the CSA
* DEA was created in 1973 and replaced:  
* Bureau of Narcotics and Dangerous Drugs
* Office for Drug Abuse Law Enforcement
* Office of National Narcotic Intelligence 

State and Federal Authority

* State Law **should not** **be less strict** than federal law
* Pharmacist must follow the stricter of the state and federal law
* If there is no State Law you must follow Federal Law

Schedules of controlled substances

* Controlled substances under the CSA are divided into **five** schedules (I, II, III, IV, V)

Schedule I Controlled Substances

* **High potential for abuse**, have **no currently accepted medical use** in treatment in the US, and there is a lack of accepted safety for use of the drug or other substance under medical supervision
* heroin
* lysergic acid diethylamide (LSD)
* marijuana (cannabis)
* peyote
* methaqualone
* 3,4-methylenedioxymethamphetamine(“MDMA”)

Schedule II Controlled Substances

* **High potential for abuse** which may lead to severe psychological or physical dependence, and **have a currently accepted medical use** in treatment in the US or a currently accepted medical use with severe restrictions
* Morphine
* Codeine
* Opium
* Hydrocodone (Maxidone, Zydone, Vicodin, Lortab, Vicoprofen, Reprexain),
* Hydromorphone (Dilaudid)
* Methadone (Dolophine)
* Meperidine (Demerol)
* Oxycodone(OxyContin)
* Fentanyl (Sublimaze or Duragesic)
* Amphetamine (Dexedrine, Adderall)
* Methamphetamine (Desoxyn)
* Methylphenidate (Ritalin)
* Lisdexamfetamine (Vyvanse).
* Cocaine
* Amobarbital
* Glutethimide

Schedule III Controlled Substances

* Potential for **abuse less than substances in Schedules I or II** and abuse may lead to moderate or **low physical dependence** or **high psychological dependence**
* Tylenol with Codeine(not more than 90 milligrams of codeine per dosage unit)
* Buprenorphine (Suboxone)
* Schedule III non-narcotics include:
* Benzphetamine (Didrex)
* Phendimetrazine
* Ketamine
* Anabolic steroids(Testosterone)

Schedule IV Controlled Substances

* **Low potential for abuse** relative to substances in Schedule III, have a **currently accepted medical use in treatment in the US**, and abuse may lead to **limited physical dependence or psychological dependence** relative to substances in schedule III.
* tramadol (Ultram)
* alprazolam (Xanax)
* clonazepam (Klonopin)
* clorazepate(Tranxene)
* diazepam (Valium)
* lorazepam (Ativan)
* midazolam (Versed)
* temazepam (Restoril)
* triazolam (Halcion)

Schedule V Controlled Substances

* **Low potential for abuse** relative to substances listed in schedule IV, **have a currently accepted medical use in treatment in the US**, and abuse may lead to **limited physical dependence or psychological dependence** relative to substances in schedule IV
* Preparations containing limited quantities of certain narcotics
* Cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC and Phenergan with Codeine)

Who has scheduling authority?

* Secretary of the Department of Health and Human Services (DHHS)

What does the DHHS provide?

* Provides information on:
* Abuse potential
* Pharmacological effects
* State of current scientific knowledge
* History and current pattern of abuse
* Scope, duration and significance of abuse
* Risk to public health
* Dependence liability
* Precursor to a current controlled substance

To whom does the DHHS provide information to?

* To the attorney general (AG)
* The Attorney General can:
* Add (tramadol)
* Remove (marijuana?? Maybe someday)
* Change(Hydrocodone combos)
* If the Secretary recommends not to Schedule, the AG must comply
* Exception is if “imminent hazard to the public safety”

Scheduling a new drug…

* Manufacturer must submit an NDA to the Secretary if the new drug has stimulant, depressant, or hallucinogenic effect on the CNS.
* The Secretary must forward the information to the AG if the drug has abuse potential.

Registration

* Required to register (license) with the DEA if you manufacture, distribute, or dispense


* Manufacturers and Distributors every 1 year
* Dispensers every 3 years (Pharmacies)


* Exemptions:
* Employee acting in usual course of business (Pharmacist)
* Common or contract carrier in the usual course of business (Cardinal Driver)
* End user (Patient)

Prescriber Registration

* Individual Practitioners must be registered with the DEA to **prescribe:**
* Physician
* Dentist
* Veterinarian
* Others
* Exceptions:
* Hospital intern, resident, or foreign-trained physician

Pharmacy Registration

* Every pharmacy that dispenses a controlled substance must be registered with DEA
* Must have a State license first
* Use Form 224
* Cost $888.00
* Multiple Pharmacies = DEA license for each pharmacy
* Corporations with 50 or more retail pharmacy registrations or distributors with 10 or more registered locations there is a process to do them all at once
* Renewed every 3 years using Form 224a online no earlier than 60 days prior to the current expiration date
* Change of Business Address
* modification of registration can be requested online or in writing to the local DEA Registration Program Specialist
* Must maintain the **new certificate with the old certificate until expiration**
* Change in State you must have new state license before modification
* Termination of Registration
* must return its DEA registration certificate and unused official order forms to the local DEA Registration Program Specialist

Transfer of Business

* Transfer of Business
* pharmacy registrant must submit in person or by registered or certified mail, return receipt requested, to the Special Agent in Charge in his or her area, at **least 14 days** **in advance** of the date of the proposed transfer


1. The name, address, registration number, and authorized business activity of the registrant discontinuing the business (registrant-transferor)
2. The name, address, registration number, and authorized business activity of the person acquiring the business (registrant-transferee)
3. Whether the business activities will be continued at the location registered by the person discontinuing business, or moved to another location (if the latter, the address of the new location should be listed)
4. The date on which the transfer of controlled substances will occur

* **complete inventory** must be taken the day the controlled substances are transferred
* documents that state the drug name, dosage form, drug strength, quantity, and date transferred (CIII-CV)
* form 222 used to document CII products
* serves as final and initial inventory for the pharmacies
* copy of the inventory must be included in the records of each pharmacy
* the acquiring pharmacy must maintain all records involved in the transfer for two years

Suspension or Revocation of Registration

* DEA has the authority to suspend or revoke a DEA registration upon a finding that the registrant:


1. falsified the application
2. convicted of a felony relating to a controlled substance or a List I chemical
3. state license or registration suspended, revoked, or denied
4. committed such acts as would render its registration inconsistent with the public interest as determined under 21 U.S.C. 823(f)
5. excluded from participation in a program pursuant to 42 U.S.C. 1320a-7(a) (participation in Medicare and State health care programs)

Chemical Registration Requirements

* Registration is not required for regulated sellers of scheduled listed chemical products (SLCPs)
* ephedrine
* pseudoephedrine
* phenylpropanolamine

Ordering Control Substances (Moving CI or CII)

* Schedule I or Schedule II
* mandatory use of a single sheet DEA 222 Order Form (Oct 2021) or the electronic equivalent (Controlled Substance Ordering System) (CSOS)
* Exceptions that pertain to Pharmacy:
* Delivery from a central fill pharmacy to a retail pharmacy
* Distributions to reverse distributors and distributors by collectors and law enforcement
* Deliveries of controlled substances from ultimate users for the purpose of recalls

Completing DEA Forms 222

* typewriter, computer printer, pen, or indelible pencil
* one item may be entered on each numbered line
* number of lines completed must be noted on that form at the bottom of the form
* record the name and address of the supplier from whom the controlled substances are being ordered (one per form)
* purchaser must make a copy of the original DEA Form 222 for its records and then submit the original to the supplier (copy retained by the purchaser may be in paper or electronic form)

Power of Attorney to Sign DEA Forms 222 (POA Form)

* Needs:


1. the registrant
2. person to whom the power of attorney is being granted
3. Two witnesses

* power of attorney should be filed with executed DEA Forms 222
* must be available for inspection
* power of attorney is not submitted to DEA

Cancellation and Voiding DEA Forms 222

* purchaser may cancel part or all of an order on a DEA Form 222 by notifying the supplier in writing of the cancellation
* supplier must indicate the cancellation on the original DEA Form 222 sent by the purchaser by drawing a line through the canceled items and printing “canceled” in the space provided for the number of items shipped

Lost or Stolen DEA Forms 222

* upon discovery of the loss or theft of used or unused order forms, must immediately report the loss or theft to the local DEA Diversion Field Office
* provide the serial numbers
* If found notify the local DEA Diversion Field Office

Controlled Substance Ordering System (CSOS) – Electronic Order Forms (222)

* DEA's CSOS program allows for secure electronic controlled substances orders **without the supporting paper DEA Form 222**
* CSOS requires that **each individual purchaser enroll with DEA to acquire a CSOS digital certificate**

CSOS Benefits

* Ordering Freedom: Can order CI through CV and no line limit
* Faster Transactions: timely and accurate validation by the supplier
* Accurate Orders: CSOS reduces the number of ordering errors


* Decreased Cost: Order accuracy and decreased paperwork result in a lower transaction cost

Ordering Schedules III-V Controlled Substances

* must keep a receipt (**invoice or packing slip**) on which it records the date the drugs were received and **confirm that the order is accurate**
* The name of the substance
* Each finished form (10-milligram tablet) the number of units or volume of finished form in each commercial container (e.g., 100-tablet bottle or 3-milliliter vial)
* The number of units of finished forms and/or commercial containers acquired from other persons, including the date of and number of units and/or commercial containers in each acquisition to inventory and the name, address, and registration number of the person from whom the units were acquired
* The number of commercial containers distributed to other persons and as above
* The number of units of finished forms and/or commercial containers distributed or disposed of in any other manner by the registrant as above
* Receipts must be maintained separately from all other records of the registrant

What is an “inventory”?

* An “inventory” is a **complete and accurate list** of all stocks and forms of controlled substances in the possession of the registrant on the date the inventory is taken

Inventory Requirements

* **CII** controlled substances will be determined by an **actual physical count** (to the tablet/ml/capsule,etc.)
* **CIII, CIV, or CV** controlled substance an open bottle which contains no more than 1,000 tablets, make an **estimated count** or measure of the contents
* **CIII, CIV, or CV greater than 1000** count an **exact count** of the contents must be made
* All inventory records be maintained at the registered location for at least **two years CII controlled substances** must be kept **separate** from all other records of the pharmacy
* **CIII, CIV and CV controlled substances** must be maintained either **separately from all other records** of the pharmacy or in such form that the information required is readily retrievable from ordinary business records of the pharmacy

Initial Inventory Requirements

* registrant must take an initial inventory, which is an **actual physical count of all controlled substances in their possession**
* record **open or close of business day**
* if **zero** you must make a record showing a zero inventory
* **no requirement to submit** a copy of the inventory to DEA

Biennial Inventory

* at least **every two years**, which requires the same information as the initial inventory


* no requirement to submit a copy of the inventory to DEA

Inventory for Damaged, Defective, or Impure Substances inventories must include…

1. name of the substance
2. total quantity of the substance
3. reason for the substance being maintained by the registrant and whether such substance is capable of use in the manufacture of any controlled substance in finished form (outdates)

Notes on Inventory

* Although the it is not required by law, DEA recommends that registrants keep an inventory record that includes the **name, address, and DEA registration number of the registrant**, and the **signature** of the person or persons responsible for taking the inventory.


* Open or close of business Day
* Package sizes bust be listed separately (3X100 and 1X500 Total in stock 800 tablets)

Record-keeping Requirements

* All required records concerning controlled substances must be maintained for at **least two years** for inspection and copying by duly authorized DEA officials
* **schedule II** controlled substances must be maintained **separately** from all other records
* III, IV, and V controlled substances must be maintained either separately from all other records or in such a form that the information required is readily retrievable from the ordinary business records

What is **readily retrievable** defined as?

1. Records kept by **automatic data processing systems** or other **electronic or mechanized recordkeeping systems** in such a manner that they can be separated out from all other records in a reasonable time, and/or


2. Records kept in such a manner that certain items are **asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records**

Which records must be maintained by a pharmacy?

1. DEA Form 222 or the electronic equivalent
2. Power of Attorney authorization to sign order forms
3. Receipts and/or invoices for schedules III, IV, and V controlled substances
4. All inventory records of controlled substances, including the initial and biennial inventories, dated as of beginning or close of business
5. Records of controlled substances distributed (i.e., sales to other registrants, returns to vendors, distributions to reverse distributors)
6. The Suspicious Orders Report System (SORS) should be accessed on-line and only be used by DEA registrants that distribute controlled substances to other DEA registrants (N/A)
7. Records of controlled substances dispensed, to include prescriptions or a logbook of controlled substances which may be lawfully dispensed without a prescription
8. Reports of Theft or Significant Loss Form 106
9. Registrant Record of Controlled Substances **Destroyed** (DEA Form 41), if applicable
10. DEA registration certificate
11. The self-certification certificate and logbook (or electronic equivalent) as required under the Combat Methamphetamine Epidemic Act of 2005

Central Record-keeping

* A registrant may maintain **shipping** and **financial** records **only**
* must submit written notification of its intention by registered or certified mail, return receipt requested, in triplicate, to the Special Agent in Charge of the local DEA Diversion Field Office in which the registrant is located
* Unless the registrant is informed by DEA they are denied, begin maintaining central records 14 days after DEA receives this notification
* NOT for not executed official order forms(Form 222), controlled substance prescriptions, and  controlled substance inventories

Pharmacies have two options for filing paper prescription records…

* Option 1 (**three separate files**)
* A file for Schedule II controlled substances dispensed
* A file for Schedules III, IV, and V substances dispensed
* A file for all noncontrolled drugs dispensed.


* Option 2 (**two separate files**)
* A file for Schedule II controlled substances dispensed
* A file for all other drugs dispensed (controlled prescriptions must be readily retrievable by use of a red “C” stamp not less than one inch high

Electronic Prescription Records

* If a prescription is created, signed, transmitted, and received electronically, all records related to that prescription must be retained electronically.
* Electronic records must be maintained electronically for two years from the date of their creation or receipt. (NYS different)
* Records regarding controlled substances must be readily retrievable from all other records. Electronic records must be easily readable or easily rendered into a format that a person can read

Corresponding liability

* To dispense controlled substances, a pharmacist must know the requirements for a valid prescription.
* “A **corresponding liability** rests upon the pharmacist, including a pharmacist employed by a central fill pharmacy, who fills a prescription not prepared in the form prescribed by DEA regulations” (21 CFR 1306.05(f))

Valid Prescription Requirements

A prescription for a controlled substance must include


1. Date written
2. Prescriber signature
3. Patient Full Name and address
4. Prescriber Full Name and address
5. Prescriber DEA number
6. Drug name
7. Drug strength
8. Dosage form
9. Quantity prescribed
10. Directions for use
11. Number of refills authorized (if any)

Schedules III-V Controlled Substances- Refills

* Schedules III and IV controlled substances may be refilled if authorized on the prescription. However, the prescription may only be refilled up to five times within six months after the date of issue. After five refills or after six months, whichever occurs first, a new prescription is required
* Entered on to the back of the prescription when refilled:


1. pharmacist’s **initials**


2. the **date** the prescription was refilled


3. the **amount** of drug dispensed on the refill

* A pharmacy is permitted to use an electronic record-keeping system as an alternative to the manual method for the storage and retrieval of refill information for original paper prescription orders for schedules III and IV controlled substances.

Construction of Valid DEA Numbers

* First letter = Type of Registration
* A/B/F/G – Hospital/Clinic/Practitioner/Teaching Institution/Pharmacy
* M – Mid-Level Practitioner
* P/R Manufacturer/Distributor/Researcher/AnalyticalLab/Importer/Exporter/Reverse Distributor/Narcotic Treatment Program
* Second letter = first letter of last name
* First 6 digits are computer generated
* Last digit is the “check” digit.
* Formula:   Check digit = \[(1st +3rd + 5th) + 2x(2nd + 4th + 6th)\] = 7th
* FA-6459300
* X= \[(6+5+3) + 2X(4+9+0)\] 
* X= 40 “0”

Purpose of Issue and Corresponding Responsibility

* “To be valid, a prescription for a controlled substance must be **issued for a legitimate medical purpose** by a practitioner acting in the usual course of professional practice. The practitioner is responsible for the proper prescribing and dispensing of controlled substances, but a **corresponding responsibility rests with the pharmacist who fills the prescription.”**
* “**A pharmacist is required to exercise sound professional judgment**, and to adhere to professional standards, when making a determination about the legitimacy of a controlled substance prescription. Such a determination is made before the prescription is dispensed. **The law does not require a pharmacist to dispense a prescription of doubtful, questionable, or suspicious medical legitimacy.”**

What can a RPH add **with** practitioner authorization?

* Practitioner DEA #
* Institutional DEA #/sufix
* Directions
* Code
* MDD
* Strength

What can a RPH add **without** practitioner authorization?

* Patient address
* Patient sex
* Patient age

What can a RPH **never** add?

* patient name
* practitioner signature
* date written
* drug name
* quantity

What can a RPH change **with** practitioner authorization?

* Practitioner DEA #
* Institutional DEA #/sufix
* Directions
* Code
* Quantity
* MDD
* Strength
* Dosage form

What can a RPH change **without** practitioner authorization?

* Patient address
* Patient sex
* Patient age

What can a RPH **never** change?

* patient name
* practitioner signature
* date written
* drug name

Who may issue a prescription for a controlled substance?

1. Authorized to prescribe controlled substances by **the jurisdiction** in which the practitioner is licensed to practice
2. **Registered with DEA** or exempted from registration (e.g., Public Health Service, Federal Bureau of Prisons, military practitioners), 21 CFR 1301.23(a), or
3. **An agent or employee of a hospital or other institution** acting in the normal course of business or employment under the registration of the hospital or other institution which is registered in lieu of the individual practitioner being registered

What does the statute define as an “agent”?

* The statute defines an “agent” as “an authorized person who acts on behalf of or at the direction of a manufacturer, distributor, or dispenser.”


1. An authorized agent of an individual practitioner may prepare a written prescription for the signature of the practitioner
2. An authorized agent, that agent may telephone the pharmacy and convey that prescription information to the pharmacist
3. The practitioner’s agent may transmit the practitioner-signed prescription by facsimile

Generally, a valid Schedule II Controlled Substance prescription ____ be communicated by Facsimile.

* may not

\-A pharmacist must receive the original, manually **signed paper prescription or an electronic** prescription **prior to dispensing** a Schedule II controlled substance

\-Exception:


1. A Person in a **Hospice or**
2. **Long Term Care Facility (LTCF)**
3. **compounded for the direct administration to a patient** by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion

\-The facsimile prescription serves as the original written prescription for the pharmacy. No further documentation is required.

Emergency Oral Communication of a Valid **Schedule II** Prescription (Federal Law)

* May Not be Delegated to an Authorized Agent
* DEA regulations limit such an emergency oral prescription to the quantity **necessary to treat the patient during the emergency period** and require that it be **followed up within 7 days by a practitioner-signed, written prescription** to the dispensing pharmacy

Oral Authorization for Schedules III-V Prescriptions (Federal Law)

* A pharmacist may dispense a controlled substance listed in schedules **III, IV, or V** pursuant to an **oral prescription** made by an individual practitioner and communicated by the **practitioner** or their authorized **agent**, and promptly reduced to writing by the pharmacist containing all information required for a valid prescription except for the signature of the practitioner.

Facsimile Prescriptions for Schedules III-V Controlled Substances

* Prescriptions for **schedules III-V** controlled substances may be transmitted by **facsimile** from the **practitioner** or the practitioner’s **agent** to the dispensing pharmacy. The facsimile is **considered to be equivalent to an original prescription** as long as the practitioner has manually signed the prescription

Electronic prescriptions- duplicates

* When a pharmacist receives a **paper or oral prescription** that indicates that it was **originally transmitted electronically** to the pharmacy, the pharmacist must check the pharmacy’s records to ensure that the electronic version was not received, and the prescription dispensed. If both prescriptions were received, the pharmacist **must mark one as void**.
* When a pharmacist receives a paper or oral prescription that indicates that it was originally transmitted electronically to another pharmacy, the pharmacist must check with that pharmacy to determine whether the prescription was received and dispensed.

Schedule II Controlled Substances things to know…

* There is **no federal time limit within which a schedule II prescription must be filled after being signed by the practitioner**
* **Pharmacist must determine** that the prescription is still needed by the patient
* An oral order is only permitted in an **emergency situation**
* Practitioner must **personally communicate** the emergency oral prescription to the pharmacist
* Quantity for **“emergency”**  not defined
* Within **7 days** must send a cover
* No refills

Schedule II Controlled Substances- Issuance of Multiple Prescriptions

* An individual practitioner may issue multiple prescriptions authorizing the patient to receive a total of up to a 90-day supply of a CII controlled substance provided the following conditions are met:


1. separate prescription must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice
2. written instructions on each prescription indicating the earliest date on which a pharmacy may fill each prescription (other than the first immediate fill)
3. does not create an undue risk of diversion or abuse
4. permissible under applicable state laws
5. fully with all other applicable requirements under the CSA and CFR, as well as any additional requirements under state law.

Schedule II Controlled Substances- Facsimile Prescriptions

* In order to **expedite the filling** of a prescription, a prescriber may transmit a schedule II prescription to the pharmacy by facsimile. The original schedule II prescription must be **presented to the pharmacist and verified against the facsimile prior to the actual dispensing of the controlled substance**


* Exceptions:


1. **Compounded for the direct administration to a patient** by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may transmit the prescription by facsimile
2. **Long-Term Care Facilities**
3. **Patient enrolled in a hospice care program**

* Generally, a Valid Schedule II Controlled Substance Prescription May Not be Communicated by Facsimile -The facsimile prescription serves as the original written prescription for the pharmacy. No further documentation is required.

Electronic Record-keeping of Schedules III-IV Refill Information (not the same as ePrescribing)

* A pharmacy is permitted to use an electronic record-keeping system as an alternative to the manual method for the storage and retrieval of refill information for original paper prescription orders for schedules III and IV controlled substances.
* Print the daily “Control Log” Sign and Date it


1. Prescribing practitioner’s name
2. Patient’s name and address
3. Quantity and date dispensed on each refill
4. Name or identification code of the dispensing pharmacist
5. Original prescription number

* In **lieu of such a printout** “Daily Control-log”, the pharmacy must maintain a bound **logbook or a separate file** in which each pharmacist involved in the day’s dispensing signs a statement.
* In case a pharmacy’s electronic system experiences downtime, the pharmacy must have a **back-up procedure** to document in writing refills of schedules III or IV controlled substances.

Transfer of Schedules III-V Prescription Information (non-ePrescriptions)

* A pharmacy may transfer prescription information for schedules III, IV, and V controlled substances to another registered pharmacy for the purpose of **refill dispensing** between pharmacies, on a **one-time basis only**.
* Transfer of any **original unfilled** prescription **not permitted**
* The transfer must be communicated directly between two licensed pharmacists

Transferring pharmacist must record the following information:

1. Write the word “VOID” on the face of the prescription
2. Record on the **reverse** of the prescription the **name, address, and DEA registration number of the pharmacy** to which it was transferred and the name of the **pharmacist receiving** the prescription information
3. **Date of the transfer** and the **name of the pharmacist** transferring the information

Receiving pharmacist must record the following information:

1. Write the word “transfer” on the face of the transferred prescription and reduce to writing all information required to be on a prescription and include:

a) **Date** of issuance of **original** prescription.

b) **Original number of refills** authorized on original prescription.

c) Date of **original dispensing**.

d) **Number of** valid **refills remaining** and **date(s) and locations of previous refill(s)**.

e) **Pharmacy’s name, address, DEA registration number, and prescription number** from which the prescription information was transferred.

f) Name of **pharmacist who transferred** the prescription.

g) Pharmacy’s name, address, DEA registration number, and prescription number from which the prescription was **originally filled (wait what ? )**

Transferring Electronic Prescriptions for Controlled Substances (EPCS)

* Electronic prescriptions being transferred **electronicall**y, the transferring pharmacist must provide the receiving pharmacist with the following information in addition to the original electronic prescription data.


1. The **date of the original dispensing**.
2. The **number of refills remaining** and the **date(s) and locations of previous refills**.
3. The **transferring pharmacy’s name, address, DEA registration number, and prescription number for each dispensing**.
4. The **name of the pharmacist transferring** the prescription.
5. The name, address, DEA registration number, and prescription number from the pharmacy that originally filled the prescription, if different. (wait what ?)

* The pharmacist receiving a transferred electronic prescription must create an electronic record that includes the receiving pharmacist’s name and all the information(listed above).

Dispensing Requirements

* Labeling 
* date of filling
* pharmacy name and address,
* Prescription number
* name of the patient,
* name of prescribing practitioner
* directions for use
* cautionary statement ***:“CAUTION: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed***.”

Emergency Oral dispensing (CII)

* the prescribing practitioner must provide a written and signed prescription to the pharmacy within **seven days** and meet the below requirements:


1. limited to the amount needed to treat the patient during the emergency period
2. prescription order must be immediately reduced to writing by the pharmacist and must contain all required information
3. reasonable effort to determine that the oral authorization came from a registered individual practitioner
4. cover with in 7 days (written on its face “Authorization for Emergency Dispensing” and the date of the oral order)
5. dispensing pharmacist must attach this written prescription to the oral emergency prescription
6. pharmacist must notify the local DEA Diversion Field Office if the prescriber fails to provide a written prescription within 7 days
7. For electronic prescriptions, the pharmacist must annotate the record of the electronic prescription with the original authorization and date of the oral order

Partial Dispensing of Schedule II Controlled

* pharmacist is unable to supply the full quantity of a written or emergency oral (telephone) prescription
* notes the quantity supplied on the front of the prescription or in the electronic prescription record
* remaining portion may be dispensed within 72 hours
* if the remaining portion is not or cannot be filled within the 72 hour period, the pharmacist must notify the prescribing practitioner
* no further quantity may be supplied beyond 72 hours without a new prescription
* Note \*\*patient is not required to pick up the balance of the prescription within that 72-hour limit

Comprehensive Addiction and Recovery Act of 2016

* Permits a prescription for a controlled substance in **CII** to be partially filled at the request of the patient or the prescribing practitioner if:


1. partial filling is not prohibited by **state law (Prohibited in NY)**
2. prescription is written and filled in accordance with the CSA
3. total quantity dispensed in all partial fillings **does not exceed the total quantity prescribed**
4. shall be **filled not later than 30 days after the date on which the prescription was written**

Partial Filling of **CII** Prescriptions for Terminally ill or Long-Term Care Facility (LTCF) Patients

* An LTCF is defined in the CFR as a nursing home, retirement care, mental care, or other facility or institution, which provides extended health care to resident patients
* For a patient in an LTCF or for a patient with a medical diagnosis documenting a terminal illness, may be filled in partial quantities to include individual dosage units
* Pharmacist and the prescribing practitioner have a **corresponding responsibility** to assure that the controlled substance is for a terminally ill patient
* pharmacist **must record on the prescription** whether the patient is **“terminally ill” or an “LTCF patient.”**
* **date of the partial filling, quantity dispensed, remaining quantity authorized to be dispensed, and the identification of the dispensing pharmacist**
* CII prescriptions for patients in an LTCF or terminally ill patients are **valid for a period not to exceed 60** days from the issue date

Partial Dispensing Schedule III-V Controlled Substances

* each partial filling is recorded in the same manner as a refilling
* partial fillings does **not exceed the total quantity prescribed**
* no dispensing occurs beyond **six months** from the date on which the prescription was issued

Dispensing Without a Prescription

* Dispensing a controlled substance without a prescription
* The regulation states that a controlled substance listed in schedules II, III, IV, or V which is not a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, may be dispensed by a pharmacist without a prescription to a purchaser at retail, provided that:


1. dispensing is made only by a pharmacist ONLY
2. Not more than **240cc or 48 dosages** of any such controlled substance containing **opium in 48 hours**
3. Not more than **120cc or 24 dosages** of any such controlled substance containing **any other such controlled** substance **in 48 hours**
4. purchaser is at least 18 years of age
5. suitable identification (including proof of age where appropriate)
6. bound record book that contains the **name and address** of the **purchaser**, the **name and quantity of the controlled substance** purchased, the **date** of each purchase, and the **name or initials of the pharmacist** who dispensed the substance to the purchaser
7. prescription is not required for distribution or dispensing of the substance pursuant to any other federal**, state or local law**
8. **Central fill pharmacies may not dispense controlled substances at the retail level to a purchaser**

Disposal of Controlled Substances

1. Promptly destroy that controlled substance using an **on-site** method of destruction **“shall be rendered non-retrievable”**

a) Use a DEA Form 41


2. **Reverse distributor** (Inmar)
3. For the purpose of return or recall return to registered person from whom it was obtained **(Cardinal or Smith)**
4. Request assistance from the **Special Agent in Charge** of the Administration in the area in which the practitioner is located

Authorized Collectors -Receptacles

* Authorized collectors may receive a controlled substance for the purpose of destruction from an ultimate user
* Retail pharmacies and hospitals/clinics with on-site pharmacies may **modify their registrations** to obtain authorization to be a collector.
* **ultimate users are able to carry** their unwanted pharmaceutical controlled substances to an authorized retail pharmacy, authorized hospital clinic with an on-site pharmacy, or other authorized collector location and deposit their unwanted or expired controlled substances in a secure container for disposal
* controlled substances that are **lawfully possessed** by an ultimate user or other authorized non-registrant person **may be collected**
* Authorized collectors shall **not permit an ultimate user to transfer such substance to any person for any reason**
* **shall not be counted, sorted, inventoried, or otherwise individually handled**

Collection Receptacles at Long-Term Care Facilities

* Only authorized retail pharmacies and authorized hospitals/clinics with an on-site pharmacy may install, manage, and maintain collection receptacles at LTCFs and remove seal, transfer, and store, or supervise the removal, sealing, transfer, and storage of sealed inner liners at LTCFs
* Maintenance is performed by **employee of the authorized retail pharmacy** and one supervisor-level **employee of the LTCF** or **two employees of the authorized collector**

Central Fill Pharmacy

* Central fill pharmacies are permitted to prepare both initial and refill prescriptions
* Prescriptions for controlled substances listed in schedules II, III, IV, or V may be transmitted electronically from a retail pharmacy to a central fill pharmacy including via facsimile

The retail pharmacy __transmitting__ the prescription information must:

1. Write the words **“CENTRAL FILL” on the face of the original prescription** and **record the name, address, and DEA** registration number of the central fill pharmacy to which the prescription has been transmitted and the name of the retail pharmacy **pharmacist transmitting** the prescription, and the **date** of transmittal
2. Ensure that all information required to be on a prescription is transmitted to the central fill pharmacy
3. Maintain the original prescription for a period of two years
4. Keep a record of receipt of the filled prescription, including the date of receipt, the method of delivery (private, common, or contract carrier) and the name of the retail pharmacy employee accepting delivery
5. For schedules III-V prescriptions, indicate in the information transmitted the number of refills already dispensed and the number of refills remaining

The central fill pharmacy __receiving__ the transmitted prescription must:

* Keep a **copy of the prescription**
* Keep **a record of the date of receipt of the transmitted prescription**, the name of the **licensed pharmacist filling the prescription**, and **dates of filling or refilling of the prescription**
* Keep a record of the **date the filled prescription was delivered** to the retail pharmacy and the **method of delivery**

Bureau of Narcotic Enforcement (BNE)

* Public Health Initiatives & Administration
* Administers Official Prescription Program, Prescription Monitoring Program, Electronic Prescribing Mandate, Mandatory Prescriber Education, and grants
* Conducts education and outreach
* Helps formulate policy and regulations
* Narcotic Investigations
* Conducts investigations, inspections, outreach
* Partners with law enforcement and regulatory agencies
* Data Analysis
* Reviews incoming data to ensure timeliness and accuracy
* Works with IT on all new initiatives
* Conducts data analysis for Bureau initiatives
* Regulatory Compliance
* Issues licenses, certifications, and permits

Prescription Drug Reform Act 2012

* Part A: I-STOP/PMP
* Part B: Electronic Prescribing
* Part C: Controlled Substance Schedule Changes
* Part D: Prescription Pain Medication Awareness Work Group
* Part E: Safe Disposal Program

Opioid Legislation 2016

* Part A: Mandatory Prescriber Education
* Part B: Treatment Coverage by Insurance Companies
* Part C: Prescribing for Acute Pain
* Part D: Controlled Substance Handouts and Pharmacy Services

Prescription Monitoring Program (PMP)

* A statewide electronic database which collects designated data on the dispensing and distribution of controlled substances. Data is viewed by individuals who are authorized under state law to receive the information
* The registry includes patient-specific information on dispensed controlled substances
* Patient data is derived from pharmacy dispensing information
* Accurate pharmacy data entry is a must!
* 1 year of patient history is displayed
* Data is visible within 24 hours of submission

Health care practitioners can use the PMP to:

* Better evaluate patients’ treatment with controlled substances


* Determine whether there may be misuse of controlled substances
* Reduce diversion of controlled substances by identifying individuals potentially engaged in ‘Doctor Shopping’

Practitioner Access to the PMP

* On August 27, 2013, the updated PMP and the mandatory duty to consult for practitioners was officially implemented
* Practitioners __must__ consult the registry in most cases prior to prescribing or dispensing any controlled substance listed in Schedule II, III, or IV
* The data considered by the practitioner must be obtained from the PMP Registry no more than 24 hours before the prescription is issued
* Practitioners __do not__ need to include a reference that they checked the PMP on the prescription
* Pharmacists are encouraged but __not__ mandated to consult the PMP Registry

Pharmacist Access to PMP Registry

* Pharmacists may designate ONLY another pharmacist or pharmacy intern
* Pharmacy technicians and other pharmacy employees are PROHIBITED from access to the PMP Registry
* Pharmacists are PROHIBITED from providing a PMP report, upon request, for any law enforcement official, including a DEA agent
* Pharmacist may NOT access the PMP Registry for someone for whom they do NOT have a prescription
* Passwords are NOT to be shared!

How to Access the PMP

It is necessary to obtain a Health Commerce System (HCS) account, to provide secure online access to an individual’s recent controlled substance prescription history

Schedule II-V Medications Not Yet Scheduled in New York State

* DEA Schedule II:
* Dronabinol Oral Solution
* Oliceridine
* DEA Schedule III:
* Perampanel
* DEA Schedule IV:
* Alfaxalone, Brexanolone, Daridoexant, Eluxadoline, Lemborexant, Lorcaserin, Remimazolam, Serdexmethylphenidate, Solriamfetol, Suvorexant
* DEA Schedule V:
* Brivaracetam, Cenobamate, Ganaxolone, Lasmiditan

Access to Other States PMP Data

* Not all states are interoperable with each other.
* Practitioners or users/designees in New York may or may not have access to view other states’ PMP data, and that access depends on what access is legally allowed in the other states. For example, some states may not allow a designee or pharmacist access.
* In New York State’s PMP, the other states’ data will display in the same manner as the New York data appears.
* The information New York requires may not be displayed in the other state’s data if that information is not required by the other state. Such as:
* Certain schedules – other states may only require CII data
* Payment Type

Pharmacists PMP Data Collection Tool

* Required patient-specific information is defined in statute and regulation
* Controlled substance dispensed data reporting is required no later than 24 hours after the substance was delivered
* All data submitted to BNE as a file upload or transfer must be submitted using the American Society for Automation in Pharmacy (ASAP) 4.2, 4.2A, or 4.2B standard of reporting

PMP Data Submission

* After receiving controlled substance prescription data, BNE:
* De-duplicates any identical records;
* Matches new record to existing patient records;
* Presents new record in the PMP Registry;
* Screens all records for warnings and errors;
* Rejects any record containing an error;
* Records with errors are NOT uploaded to the PMP Registry
* Errors shall be corrected within 72 hours

PMP Data Submission --Supervising Pharmacist/Owner Responsibility

* Check daily for errors and correct
* Know what your vendor is doing on your behalf!
* Be sure your data is being submitted in ASAP 4.2, 4.2A, or 4.2B
* Add, change, or remove a pharmacist or employee from the Controlled Substance Prescription Data “Role” (submitter, reviewer)

Why is it important that accurate data is received from the pharmacy?

* It’s The Law!
* Records with errors are NOT uploaded to the PMP Registry
* Records NOT displayed in the PMP Registry do NOT provide an accurate history of the patient
* Suspicious activity may be overlooked by the prescriber
* Other states’ practitioners viewing the PMP Registry expect NYS data to be accurate

Prescription Monitoring Program Webinars/ Enhancements

* Mobile Friendly - On average, there was a 151% increase in mobile traffic when comparing the 60 days prior to Mobile Friendly PMP Launch to the 60 days post launch.
* MME Calculator - Morphine Milligram Equivalent (MME) calculator tool within the Prescription Monitoring Program Registry

Electronic Prescribing Defined

* A prescription issued with an electronic signature and transmitted by electronic means in accordance with regulations of the commissioner and the commissioner of education and consistent with federal requirements.
* A prescription generated on an electronic system that is printed out or transmitted via facsimile is **not** considered an electronic prescription and must be manually signed.
* Electronic prescribing is a paperless process.
* Electronic prescriptions must remain electronic.
* It is not necessary to print the electronic prescription for filing purposes because the electronic prescription is mandated to be archived electronically.

Annotation

* When a pharmacist fills a prescription in a manner that would require the pharmacist to make a notation on the prescription, if the prescription were written, the pharmacist shall make the same notation electronically when filling an electronic prescription and retain the annotation electronically in the prescription record.


* When a prescription is received electronically, the prescription and all required annotations shall be retained electronically.
* Information authorized to be added or changed by the pharmacist on an electronic prescription, **MUST** be annotated electronically and archived for 5 years.

Electronic Prescribing of Controlled Substances (EPCS)

* Issuing and dispensing laws and regulations for controlled substances remained the same regarding electronic prescriptions as for paper prescriptions. Only the format changed.

DEA Interim Final Rule (IFR) Background

* Effective June 1, 2010
* Allows for electronic prescribing of controlled substances.
* The rule may be accessed via the U.S Department of Justice, DEA Office of Diversion Control website.

Pharmacy Software Application Requirements:

* Must allow downloading of prescription data into a database or spreadsheet that is readable and sortable
* Must allow for pharmacist annotations to be maintained electronically
* Must be capable of retrieving controlled substance prescriptions by practitioner name, patient name, drug name and date dispensed
* Must maintain an audit trail of a number of actions (e.g. receipt, annotation, alteration, changes in logical access)
* Must conduct internal audits and protect records
* Must retain archived records electronically

EPCS – Practitioners & Pharmacists

* Prescribing & dispensing applications must meet security standards set forth by the DEA for e-prescribing controlled substances
* Practitioners require a two-factor authentication to ensure prescription integrity and non-repudiation
* Pharmacies may only process controlled substance prescriptions using a certified pharmacy application
* Certified computer applications for both the practitioner and pharmacy must be registered with BNE

Registration of a Certified Pharmacy Application

* Note: BNE does not certify software applications
* Registration is required, whichever occurs first:
* At least every two years, or whenever functionality related to controlled substance prescription requirements is altered with the computer application
* Registration process is available online through the Health Commerce System
* The online HCS application is called ROPES
* Instructions can be found on the BNE website