Week 8, 9, & 10: Controlled Substances Part 1

qualifying PAs and NPs

24 hours of initial training addressing each of the topics in 21 USC 823(g)(2) (G)(ii)(IV) o 8‐hour DATA‐waiver course for treatment of opioid use disorder (same program as physicians) o 16 hours - SAMHSA will offer training via the PCSS‐MAT

The CSPMP is not open to the public. Only the following people can access these records

A person who is authorized to prescribe or dispense a controlled substance to assist that person to provide medical or pharmaceutical care to a patient or to evaluate a patient -Authorized persons (prescribers and pharmacists) may delegate the ability to access the CSPMP to the following personnel: --licensed personnel --unlicensed personnel --pharmacist delegates: licensed personnel only An individual who requests his or her own controlled substance prescription information A professional licensing board when the information is necessary for an open investigation or complaint A local, state, or federal law enforcement or criminal justice agency when the information is necessary for an open investigation or complaint The Arizona Health Care Cost Containment System Administration regarding individuals who are receiving their services A person serving a lawful order of a court of competent jurisdiction The Board staff for purposes of administration and enforcement

physicians with multiple DEA numbers and multiple offices

A prescriber is required to have an individual DEA registration for each location where they do the following regarding CS: o Prescribe, AND o Administer, OR o Dispense If a prescriber has an individual DEA number for an individual office location, the DEA number on the prescription order will need to be the one for the specific office location where the prescriber "wrote" the prescription order. Physicians with one (1) DEA number and multiple offices (who ONLY prescribe CS) A prescriber, if they only PRESCRIBE controlled substances from any given location in a given state is ONLY required to have one (1) DEA number for the office locations in that state. The address to be used when filling the controlled substance prescription order is to be the one that the prescriber was at when they wrote the prescription order.

the receiving pharmacist must record

All information required on a CS prescription (see the section entitled "All CS prescriptions must include the following information:") The word "Transfer" on the face of the prescription For e‐prescriptions, the transfer record itself is sufficient Date of transfer Prescription number from sending pharmacy Date of issue Date first dispensed Original number of refills Number of valid refills remaining and date(s) and location(s) of previous refill(s). DatesandlocationsofpreviousfillsforCS(21CFR1306.25-Fedis stricter than state) Thename,address,DEAregistrationnumberandprescriptionnumber from the pharmacy that originally filled the prescription, if different than the one currently transferring the prescription to the receiving pharmacy (21 CFR 1306.25) Pharmacy's name, address, telephone number, and DEA registration of the sending pharmacy ...and of the pharmacy where the prescription was first filled, if different Name of sending pharmacist Name of receiving pharmacist

opioid epidemic act and clean up bills - pharmacist responsibilities regarding CII opioids

CII opioid prescriptions that exceed the 5‐day supply or a new prescription that exceeds 90 MMEs/day is presumed to be exempt from statutory limitations o What this means - pharmacists are not required to verify a prescription's exemption status with the prescriber

Controlled Substance Ordering System

CSOS allows registrants to transmit orders for any controlled substances electronically (C‐I to C‐V) Every individual person who is the DEA registrant or who has been granted power of attorney and wants to sign electronic orders for controlled substances must first enroll with DEA to acquire his or her own personal CSOS "key" Orders are signed electronically using your "private key" stored on a physical device that is under sole control of the registered individual Report the loss of your key to the CSOS Certification Authority within 24 hours

1. prescription orders for controlled substances - CS prescription requirements

C‐II prescriptions must be written in ink, indelible pencil, or printed Be issued for a legitimate medical purpose Be written by a practitioner acting in the usual course of his/her professional practice The practitioner must have conducted at least one in‐person medical evaluation of the patient Must be written for an ultimate user (i.e. writing a prescription "For Office Use" is prohibited) Cannot contain more than one CII drug per prescription blank (AZ) (ARS36‐2525 A) Must be from a prescriber licensed in the U.S. (i.e. no CS prescriptions from any foreign country) (AZ) AZ recognizes out‐of‐state prescribers (note not all states do)

Use of CSPMP is voluntary by pharmacists

DEA is saying that accessing the CSPMP is part of the pharmacist's corresponding responsibility.

additional information required for e-prescriptions (AZ)

Date of transmission Name of individual transmitting the prescription, if not the prescriber

additional information required for faxed prescription (AZ)

Date of transmission Telephone number of prescriber Fax number Name of individual faxing the prescription, if not the prescriber

Responsibilities of Pharmacy Permit Holders

Establish written policies and procedures

Pharmacy Requirements

First recipient of the e‐Rx (pharmacy or application service provider) must digitally sign and the pharmacy must archive the e‐Rx. If transmission of an e‐prescription fails... (you'd only know this if you receive an e‐prescription, but the data is somehow corrupt) o Prescriber may write a copy of the transmitted prescription and sign it Copy must indicate that it was originally transmitted to a specific pharmacy and that the transmission failed. o Pharmacy must check records to ensure that the e‐Rx was not received or dispensed (either at its pharmacy or another pharmacy) before it dispenses based on the paper prescription. If the electronic version was received... o If the paper/oral prescription and e‐prescription are at different sites, mark the paper prescription as void o If the paper/oral prescription and e‐prescription are at the same site, you make mark either prescription as void, but remember that a paper CS prescription must comply with all DEA requirements for any paper prescription, including a manual signature

All CS prescriptions must include the following information

Full name and address of the patient For an animal, owner's name (AZ) and species of animal Full name, address and telephone number of the prescriber DEA number of the prescriber Remember that some prescribers are exempt from DEA registration and will instead use an identifier at their institution Date issued Drug name, dosage form, strength, and quantity Directions for use Prescriber's signature Must be manually signed (pre‐printed or stamped signatures are prohibited) or Electronic/digital signature in electronically‐transmitted prescriptions or Electronic only signature on prescription orders generated by electronic media (EMR/EHR) MUST be printed security paper that prevents copying or alteration or Electronic signature with manual signature/initials are allowed for prescription orders generated by electronic media (EMR/EHR) on regular paper are allowed or Not required for orally‐transmitted prescriptions (RPh signs for prescriber) Refills if authorized

Schedule II

Have a high abuse potential Have a currently accepted medical use in treatment in the US Abuse of the drug or other substance may lead to severe physical or psychological dependence

Schedule IV

Have a low abuse potential relative to drugs in C‐III Have a currently accepted medical use in treatment in the US When abused may lead to limited physical or psychological dependence relative to drugs in C‐III

Schedule III

Have an abuse potential less than C‐I or C‐II drugs Have a currently accepted medical use in treatment in the US When abused may lead to moderate or low physical dependence or high psychological dependence

Schedule V

Have an abuse potential less than C‐IV drugs Have a currently accepted medical use in treatment in the US When abused may lead to limited physical or psychological dependence relative to drugs in C‐IV

qualifying MD/DOs must meet one or more of the following criteria

Hold subspecialty board certification in addiction psychiatry or, Hold an addiction certification or, Hold a subspecialty board certification in addiction medicine must Completed required training for the treatment and management of patients with opioid use disorders (8 hours of training) Participated as an investigator in one or more clinical trials leading to the approval of a narcotic medication in CIII, CIV, or CV for maintenance or detoxification treatment Have other training experience that the state medical licensing board considers a demonstration of the physicians ability to treat and manage patients with opioid dependency Have completed other training or experience that HHS considers a demonstration of the physician's ability to treat and manage patients with opioid dependency.

who are midlevel practioners?

Homeopathic Physician/Naturopathic Physician Optometrists Physician Assistants Pharmacists (if granted prescribing authority in state of licensure) Registered Nurse Practitioners

Education to be Provided for an Opioid Antagonist Dispensed without a Prescription order

How to prevent an opioid‐related overdose How to recognize an opioid‐related overdose How to administer an opioid antagonist safely to an individual experiencing an opioid‐related overdose Precautions: o Potential side effects and o Possible adverse events associated with administration of the opioid antagonist; AND Confidentiality, security, and privileged nature of documentation of opioid antagonists dispensed under ARS 32‐1979.

An "Emergency Situation" Exists only when these three factors are present

Immediate administration of the CS is necessary for proper treatment No appropriate alternative treatment is available, including administration of a CS that is not a C‐II It is not feasible for the prescriber to provide a written prescription prior to the dispensing the CS

Documentation requirements for dispensing opioid antagonists without a prescription order

Include information required under R4‐23‐407(A)(1)(a,c,d,f, and l) and (A)(2) o Date of issuance; o Drug name, strength, and dosage form or device name; o Name of the drug's or device's manufacturer or distributor if the prescription order is written generically or a substitution is made; o Date of dispensing; o Name or initials of the dispensing pharmacist; o A prescription order is kept by the pharmacist or pharmacy permittee as a record of the dispensing of a drug or device for seven years from the date the drug or device is Also include the following: o Quantity dispensed o Directions for use; and o If available, the patient's name, address, telephone number, and birth date; or o Name, address, telephone number, and birth date of a family member in position to assist the individual at risk of an opioid‐related overdose; or o Name, address, telephone number, and entity at which employed of a community member in a position to assist an individual at risk of an opioid‐ related overdose; and o Name of the individual providing the education required under subsection (B)(2)

how long do i have to retain CS order records

Invoices and executed DEA 222 Forms must be maintained for a minimum of 3 years (AZ) Federal DEA requirement is only 2 years DQSA Requirement = 6 years (all inventory records) Executed DEA 222 Forms and annual CS inventory must be maintained on site Invoices may be maintained at a central location, after notifying the DEA (see DEA Pharmacist's Manual for complete explanation) Records (invoices) must be readily retrievable Comply with a DEA request within 2 business days.

A note on "Medical Marijuana"

Marijuana is currently a schedule 1 at the federal level 30 states and the District of Columbia have adopted laws legalizing marijuana in some form. o 22 states have enacted laws allowing patients with a legitimate medical need as certified by a physician the right to possess or grow marijuana o 8 states and the District of Columbia allow for recreational use Pharmacies with DEA registrations and the pharmacists who work for them are not allowed to be part of the medical marijuana distribution system because it is still a schedule I federally. CT, MN, and NY: all medical cannabis dispensaries must have a pharmacist on site to dispense the product to a patient.

Pharmacies, dispensing prescribers, and health care facilities are required to report DAILY (2014) to the board information about the controlled substances they dispensed, including:

Name, address, telephone number, prescription number, and DEA registration number of the dispenser Name, address, gender, date of birth, and telephone number of the person or, if for an animal, the owner of the animal for whom the prescription is written Name, address, telephone number, and DEA registration number of the prescribing medical practitioner (DEA and address need to match) The quantity and National Drug Code (NDC) number of the Schedule II, III, or IV controlled substance dispensed (note bill pending Governor signature that would add CVs) The date the prescription was dispensed The number of refills, if any, authorized by the medical practitioner The date the prescription was issued The method of payment identified as cash or third party Whether the prescription is new or a refill

Schedule I

No recognized medical use in this country Have a high potential for abuse Lack accepted information on safety, even under medical supervision For investiga‐ tional purposes only

Exemptions from prescriber mandatory look for AZ CSPMP

Patient is in hospice or palliative care, Patient is being treated for cancer, a cancer‐related illness or condition, or dialysis, Prescriber is administering the CS, Patient is receiving CS during the course of inpatient or residential treatment in a hospital, nursing care facility, assisted living facility, correctional facility or mental health facility Prescriber is prescribing a 10‐day supply or less of a CS for an invasive medical or dental procedure that results in acute pain, Prescriber is prescribing a 10‐day supply or less of a CS for a patient who has suffered an acute injury or medical or dental disease process that is diagnosed in an ED (emergency department) and is for acute pain; Prescriber is prescribing a 5‐day supply or less and has reviewed the CSPMP for that patient within the last 30 days, and the system show that no other prescriber has prescribed a controlled substance in the preceding 30‐day period, Prescriber uses an electronic medical record (EMR) that integrates data from the CSPMP, a review of the EMR with the integrated data shall be deemed compliant with the review of the CSPMP. o Scottsdale Health Care (Honor Health) and AZ Pain Clinic EMRs are currently integrated with the CSPMP.

Drug Addiction Treatment Act

Permits maintenance and detox outside of an OTP Qualifying physicians, physician assistants, and nurse practitioners may prescribe and dispense CIII, IV, and V opioids approved by FDA for this purpose

in a pharmacy, which of the following individuals would be able to hold power of attorney for signing the DEA form 222?

Pharmacist Pharmacy Technician Pharmacy Technician Trainee Store Manager Assistant Store Manager Clerk Any other employee of the company

Miscellaneous information on opioid antagonists

The trained pharmacist may administer an opioid antagonist to an individual the pharmacist believes is experiencing an opioid‐related overdose, and is exempt from civil liability Dispensing an opioid antagonist under ARS 32‐1979 by invoice to a community member is not wholesale distribution as defined at ARS 32‐1981.

Sending Pharmacist must record

The word "VOID" on the face of the transferred prescription For a pharmacy with computerized prescription records, this can be substituted with a record of the transfer in the system that invalidates the prescription Date of transfer Name of receiving pharmacist Name of sending pharmacist Pharmacy's name, address, telephone number, and DEA number of the receiving pharmacy

Prescriber Requirements

Two‐factor authentication method; prescriber must choose two of three factors acts as a digital signature Factors o Something you know (such as a password or PIN); or o Something you have (a hard token separate from the computer such as a personal digital assistant, cell phone or flash drive), or o Something you are (biometrics) An agent may enter the information into the system, the agent cannot submit for approval and authentication - only the prescriber can do the approval and authentication process.

Distributing

"Delivering a controlled substance other than by administration or dispensing."

Dispensing

"Delivering a controlled substance to an ultimate user pursuant to a lawful order of a practitioner, including prescribing and administering, packaging, labeling and compounding necessary to prepare for such delivery."

Some practical considerations

-for any non-routine inspection, consider contacting your employer, who may wish to then contact an attorney -if you deny consent (when consent is required) but the agents insists on inspecting anyway, document the conversation, obtain the agent's signature, and allow the agent to continue the inspection -document all that is said and done during the inspection -never refuse inspection when presented with an AIW -never sign anything that you do not completely understand

Who must register with the DEA? -manufacturers/wholesalers/distributers

-generally have CII-CV distribution registration -each distributing location requires a separate registration -requires annual renewel

Who must register with the DEA? - pharmacies

-generally have a CII-CV DISPENSING registration each dispensing location requires a separate registration(including internet and central fill pharmacies) requires renewal every 3 years

open circumstances that require a complete CS inventory

-opening a new pharmacy -discontinuation of a pharmacy -when your pharmacy accepts all CS stock from another pharmacy that is closing -change in ownership -within 10 days of change of PIC (AZ) -within 10 days of incidence of theft (AZ) -as directed by ASBP (AZ) in addition when a drug is newly scheduled, an inventory of that drug must be performed on the day it is rescheduled

Breakage or Spillage (Does not constitute a "loss" of CS)

1. Document what happened in the inventory records 2. Two witnesses must sign the inventory records 3. Save broken bottles/containers and salvage the product if possible 4. Contact the local DEA Diversion Field Office for further instructions for disposal 5. Complete DEA Form 41 (Registrants Inventory of Drugs Surrendered) Damaged goods may also be disposed of through shipment to a reverse distributor.

who is exempt from registration?

1. an agent or employee of any registered manufacturer, distributor, or dispenser including.. Individual pharmacists, because they are agents of the registered pharmacy Practitioners that are employees of a hospital Practitioners that serve in the military or other federal service (PHS, Bureau of Prisons) note: Practitioners may be assigned the DEA # of the institution they work for, with a suffix to identify themselves when prescribing CS 2. A common or contract carrier or warehouse employee FEDEX, UPS, USPS, etc. McKesson, Cardinal, Walgreens warehouse, etc. 3. An ultimate user who possess a CS lawfully (patient) 4. Law enforcement officials acting in the course of enforcing any law related to CS including AZ DPS, ASBP, local law enforcement, FBI, ATF 5. Civil defense officials and disaster relief officials May only dispense CS during times of proclaimed emergencies or disasters

if you're suspicious..

1. ask for a photo ID -tell them that it is store policy and you can't fill the prescription without ID -if patient says "My ID is in the car," then leaves, its a good bet they won't return 2. attempt to contact the prescriber -always use the phone number in the phone book or in your computer, NOT the one on the prescription! -if you say you need to clarify the order, and the patient leaves the pharmacy there is a good chance that it is a forged prescription 3. if you confirm a forgery, get a description of the person and call the local police 4. if you notice a pattern of prescription abuses, contact the DEA or the Board of Pharmacy remember you have the option of not filling any questionable prescription!

C-II partial fill requirements

1. if the partial fill is for a terminally ill patient or a patient in a LTCF... -the prescription may be partially filled for 60 days from the date of issue -pharmacists must write "terminally ill" or "LTCF patient" -the following additional information must be recorded on the back of the prescription --date --quantity dispensed --remaining quantity authorized for that fill --identification of the dispensing pharmacist OR 2. if you don't have enough medication to fill the prescription order -the balance of prescription becomes void after 72 hours from the partial fill --if you cannot or do not fill the balance, you must notify the prescriber that the prescription was not completed

Records of Dispersal (AKA how drugs leave the pharmacy)

1. prescription orders for CS 2. non prescription CV sales 3. distributions from a pharmacy to another practitioner (DEA registrant) 4. institutional medication records 5. disposal or destruction of CS 6. return of CS to pharmacies for disposal 7. records of theft or loss

three types of records must be maintained

1. record of inventory 2. records of drugs received 3. records of drugs dispersed (dispersed, transferred, sold)

surgical procedure

14-day supply limit Initial fill is defined as not previously received by the patient within 60 days of the pharmacy filling the current prescription Exempt from the 90 morphine milligram equivalent (MME)/ day rule

ASBP and the DEA have approved two methods for maintaining CS prescriptions

3 file system -one for CII's -one for CIII-CV -one for non-CS prescriptions 2 file system -one for C-IIs -one for CIII-V and for non CV prescription CIII-CV must be marked with a red "C"

Labels for dispensed CS medications

All CS medications dispensed pursuant to a prescription order must be labeled with the following information: Pharmacy name and address Rx number Patient name For an animal, the name of the owner & the species of the animal Prescriber name Directions for use and any cautionary statements, if any, contained in the prescription order Manually initial the finished label for final accuracy Date of filling In addition, for all C‐II, C‐III, and C‐IV medications dispensed pursuant to a prescription order must carry the following warning: "Caution: Federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed"

Documentation when filling a CS prescription

All legal requirements of a prescription order Serial Number Date of Dispensing Quantity dispensed Name or initials of dispensing RPH or intern name of the drug's or device's manufacturer if the prescription order is written generally or a substitution is made (AZ)

Enforcement - DEA audits

All records must be readily retrievable within 48 hours of receiving a written request from the DEA

power of attorney to sign an official order form

Any registrant (pharmacy) may authorize one or more individuals, whether or not they are located at the registered location, to obtain and execute DEA Forms 222 by granting a power of attorney to each such individual. The power of attorney must be signed by the same person who signed the most recent application for registration or renewal registration, as well as the individual being authorized to obtain and execute the DEA Forms 222. The power of attorney may be revoked at any time by the person who granted and signed the power of attorney. Only if the renewal application is signed by a different person is it necessary to grant a new power of attorney when the pharmacy completes a renewal registration. The power of attorney should be filed with executed DEA Forms 222 as a readily retrievable record. The power of attorney is not submitted to DEA.

Prescriber mandatory look at AZ CSPMP

Beginning no later than October 1, 2017, prescribers, before prescribing an opioid analgesic or a benzodiazepine CS listed in Schedule II, III, or IV: shall obtain a patient utilization report for that patient for the preceding 12 months at the beginning of each new course of treatment, and at least quarterly while the prescription is part of the treatment.

buprenorphine products that only have an indication for the treatment of pain

Belbuca [C-III] (Buccal film) Buprenex (C-III) (injectable) Butrans (C-III) (transdermal patch) All three of these products ONLY have an indication for pain. CANNOT be used off‐label for maintenance or detoxification in an OTP situation per DEA because the drug and dosage forms have not been approved for OTP.

FDA approved drugs for treatment of opioid addiction - CIII

Buprenorphine products Probuphine [C‐III] (Implant) Subutex [C‐III] (sublingual) Suboxone [C‐III] (Buprenorphine‐naloxone) Zubsolv [C‐III] (Buprenorphine‐naloxone) Subutex, Suboxone and Zubsolv have official FDA indications for the "maintenance" and "detoxification" treatment outside of an OTP a qualified physician, PA, or RNP registered with the DEA under DATA. If Subutex, Suboxone, or Zubsolv is used for off‐label use (e.g. pain), since it is a CIII, prescribers only need their regular DEA number to prescribe

expiration and refill limits

C-II = no refills, expiration date after 90 days C-III/IV - <= 5 refills, 6 months expiration C-V = unlimited refills, 1 year expiration

Editing a CS prescription

CII Prescription Orders Having consulted with a prescriber, a pharmacist may change: -date of issue -drug strength -dosage form -drug quantity -directions for use to help clarify, the DEA specifically mentions three things a pharmacist cannot alter on CII prescription -patients name -drug name = controlled substance prescribed -Prescribers name = prescriber/prescriber signature Always document the time, date, and name of the person giving authorization for corrections, and assure that the prescriber has documented the changes in the patient's chart!

How long do I have to retain CS inventory records

CS inventory records must be maintained on site for a minimum of 3 years (AZ) (Federal DEA requirement is only 2 years; DQSA = 6 years)

How long do I have to retain CS prescription order records

CS prescription orders must be maintained on site for a minimum of 7 years from the date of last fill (AZ) (Fed = 2 years) Prescriptions covered by Medicare = 10 years from date of last fill

Manufacturing under the CSA does not equal Manufacturing under the FDCA

CSA definition of MANUFACTURE = Production, preparation, propagation, compounding, or processing of a drug, either directly or indirectly. Packaging, repackaging, labeling or relabeling. Manufacturers, under their DEA registration for Manufacturing, may do the following: Distribute CI - CV it is registered to manufacture May conduct chemical analysis and preclinical research

central fill pharmacies

Central filling of CS prescriptions IS legal in Arizona. State laws regulate this practice, but the DEA also has some requirements. Central fill pharmacies CANNOT accept prescriptions directly from patients Central fill pharmacies CANNOT dispense directly to patients Controlled substance prescription can only be faxed or sent electronically to the central fill location

Federal Scheduling of Controlled Substances

Controlled substances are divided into 5 'schedules' (I-V) according to the potential of addiction with prolonged use

Return of CS to Pharmacies for Disposal

Currently - pharmacies are not allowed to take back controlled substances into the pharmacy. DEA has created a national take back program and is allowing police departments to have locked drop boxes where citizens can get rid of medications (CS and Non‐CS). Pharmacies are allowed to have take‐back program lock boxes in their facilities similar to the ones in police departments

ordering C-II medications

C‐II distribution from one DEA registrant to another must be recorded using the carbon‐copy DEA Form 222 (Unless you use CSOS...keep reading) These forms are ordered from the DEA by the registrant. They are serially numbered and come in triplicate. Copy 1/Top/Brown Sheet ‐> Sent to supplier Copy 2/Middle/ Green Sheet ‐> Sent to DEA (via supplier) Copy 3/Bottom/Blue Sheet ‐> Stays with purchaser/recipient Always note the date of receipt on the DEA 222 Form and verify the accuracy of the order. when executing 1. fill in the name and address of the supplier and today's date 2. write the drug name and strength, the quantity of the package, and the number of packages 3. this will be filled in by the supplier on copies 1 and 2

organizing invoices and forms (AZ and Fed the same)

C‐II invoices & forms must be maintained separately from all other invoices C‐III, IV, and V invoices may be... Either maintained separately from all other invoices Or combined with non‐CS invoices, but marked with a red "C"

Transferring CS prescriptions (Review)

C‐III, C‐IV, and C‐V prescriptions may be transferred one time only! Pharmacies sharing a real‐time online database may transfer up to the maximum refills permitted by law and the prescriber's authorization CIIs may never be transferred Transfers must involve two licensed pharmacists (interns cannot transfer CS prescriptions!)

Registering with the DEA

Each CS related activity requires a separate registration 1. Manufacturing CI ‐ V 2. Distributing CI - V 3. Reverse distributing controlled substances 4. Dispensing CII - V 5. Conducting research with CI 6. Conducting research with CII - V 7. Conducting a narcotic treatment program (including compounding) using any narcotic drug listed in CII - V 8. Conducting chemical analysis with CS 9. Importing CS 10. Exporting CS

Arizona Uniform Controlled Substances Act

Each state has a "uniform" CSA that is intended to mirror federal law.. -establishes a drug schedule for the state -regulates manufacturing, distribution, and dispensing of controlled substances within the state -DEA is the administrative agency that regulates controlled substances at federal level -ASBP is administrative agent that regulates controlled substances in Arizona but some significant differences do exist.. -for most part, state laws concur or act in addition to federal law -if and where two laws conflict, most stringent will prevail

E-prescribing

Electronic prescribing or "e‐prescribing" is the computer‐based electronic generation, transmission and filling of a prescription (a fax is NOT an electronic prescription) DEA rules allowing for e‐prescriptions for controlled substances (CSERx) became effective as of June 1, 2010 HOWEVER, any system transmitting or receiving CSERx must be audited and approved by a third‐party, which the DEA has just specified as of the end of September 2011 for pharmacies. Prescribers systems are also being certified - thus CS e‐prescribing is feasible at this time. Here is a graphic of which states allow e‐prescribing and for which schedule of CS.

quantity limitations

Federal Law: NO quantity limitations on the number of dosage units (# capsules/ tablets) or volume of ANY controlled substance that may be prescribed on an individual prescription order One exceptions to this rule (1) Rules for writing multiple prescriptions at a time...for the same C‐II drug...for the same patient... (Federal) Due to insurance limitations, many patients are prohibited from obtaining more than a 30‐ day supply at a time. C‐II prescriptions cannot be refilled and can only be partially filled in a few circumstances. The DEA created regulations to alleviate this inconvenience for patients. In addition to the requirements of any CS prescriptions: Limited to a 90‐day supply (total) The practitioner must write instructions on each prescription (other than the first) as to the earliest date on which the prescription may be dispensed All will have same date of issue

E prescriptions

If a pharmacy's computer system fields are automatically populated by an electronically transmitted prescription order, the automated record constitutes the original prescription and a hard‐copy or electronic image is not required

Receiving C-II's in an emergency

In an emergency a C‐II prescription may be orally transmitted by a prescriber, however... 1. The quantity prescribed and dispensed must be limited to the amount necessary to adequately treat the patient during the emergency period Typically, 72 hours‐worth of medication 2. The prescriber who authorizes the emergency C‐II must deliver a written prescription to the dispensing pharmacist within 7 days of the authorization If delivered by mail, it must be post‐marked within the 7‐day period 3. The prescription must have "Authorization for Emergency Dispensing" written on the face and the date of authorization If the prescriber fails to deliver the written prescription, the dispensing pharmacist must notify the DEA and ASBP (AZ)

Forged CS Prescriptions

In evaluating the validity of a CS prescription, the pharmacist also has a responsibility to use professional judgment to spot possible forgeries.

AZ Opioid Epidemic Act and Clean up Bills

In the 1st and 2nd Legislative Sessions of the AZ Legislature, 3 bills were passed and signed by Governor Ducey. The Opioid Epidemic Act HB 2549 Controlled Substances; Dosage Limits HB 2633 Pharmacists; Controlled Substances o HB2549 and HB2633 are considered clean‐up acts to the Opioid Epidemic Act

Theft or Loss of Controlled Substances

In the event of a theft or significant loss the local DEA office is to be notified within one business day of discovery and the ASBP is to be notified within 10 days (AAC R4‐23‐Article 9) In addition: Theft or significant loss* 1. Narcotic Division of Department of Protective Services (AZ) 2. Complete DEA Form 106 (Report of Theft or Loss of Controlled Substances) a. Indicate on DEA 106 if theft/loss was investigated by police *Significant Loss is defined in the DEA Pharmacist's Manual page 17 3. Information to be included on DEA Form 106: a. Name and address of the firm (pharmacy), b. DEA registration number, c. Date of theft or loss (or when discovered if not known), d. Name and telephone number of local police department (if notified), e. Type of theft (e.g., night break‐in, armed robbery), f. List of identifying marks, symbols, or price codes (if any) used by the pharmacy on the labels of the containers, and g. A listing of controlled substances missing, including the strength, dosage form, and size of container (in milliliters if liquid form) or corresponding National Drug Code numbers.

Evaluating the validity of CS prescription - Corresponding Responsibility

Lawful dispensing of controlled substances not only dependent on obtaining a facially‐valid prescription order! The pharmacist has a corresponding responsibility to evaluate the validity of a prescription for a controlled substance prior to dispensing. This requires using professional judgment to discern whether or not a prescription is for a legitimate medical purpose and prescribed in the usual course of practice.

Computerized documentation of CS refills

Most pharmacies today maintain computerized prescription records. In this case, refill information is recorded electronically, instead of on paper. However, each dispensing pharmacist must document daily that the computer data of the refills he or she dispensed were reviewed for accuracy. This is done in one of two forms: 1. A hard‐copy printout of each day's original and refill data 2. A log book or separate file of daily 'statements' (e.g. "I attest the accuracy of the original and refill data for prescriptions I dispensed on [DATE]") and records the following information: 1. States that original and refill data for prescriptions dispensed by each pharmacist were reviewed for accuracy 2. Printed name of each dispensing pharmacist 3. Signed and initialed by each dispensing pharmacist

Controlled Substance Prescription Monitoring Program

Most states have enacted their own electronic prescription monitoring program for controlled substances. The data generated is used to monitor for diversion, fraud, and abuse. All Prescribers (except for Veterinarians) and pharmacies with current DEA registration must be registered in the CSPMP. Registration renews every 2 years on or before May 1st. Registration ending in odd number - renew odd year, registration ending in even number - renew even year. A suspended registrant is prohibited from accessing information in the CSPMP

A note on "Narcotics"

Narcotic From the Greek 'narkos' meaning 'to numb.' It is an archaic medical term that can refer to any drug that dulls the senses, relieves pain, and induces profound sleep. The term mostly used in lay‐language to describe any illicit substance. The DEA also utilizes this term in its regulations, but they limit the definition of 'narcotic' to include opium and cocaine and all of their derivatives. In addition, it is important to note that while all 'narcotics,' by the DEA's definition, are controlled substances, not all controlled substances are narcotics. Some examples of non‐narcotic controlled substances include benzodiazepines, stimulants, steroids, etc. This becomes an important distinction regarding CII prescription orders and faxed Rx orders, hospice and LTCFs. Arizona adds cannabis to this definition Opioid An opioid is a substance that binds to opioid receptors. This includes all natural (e.g. morphine, codeine) and synthetic (e.g. oxycodone, fentanyl) derivatives of opium poppy. The term 'opioid' is the preferred term for use by medical professionals. For example, 'narcotic analgesics' is how we commonly refer to a certain class of medications, but it is more accurate to describe them as 'opioid analgesics.' (TIP: Do not confuse this with the term 'opiate,' which is a more specific term referring to natural opioids such as morphine and codeine that are extracted directly from the opium poppy.)

Ordering C-III and C-V medications

No DEA forms are required for purchase of C‐III - C‐V substances. However, the DEA does require that you maintain a record of receipt/invoice from the supplier. Drug name, Strength, Dosage form, Quantity/Package size (# of dosage units or volume of container) Number of commercial containers received Date of receipt Supplier name, address, and DEA number In addition, if controlled substances are listed with other non‐controlled substances on the invoice, they must be clearly identifiable in some manner (marked with a red asterisk or underlined in red) Always note the date of receipt on the invoice and verify the accuracy of the order!

opioid treatment programs

OTPs are accredited and certified by the Substance Abuse and Mental Health Services Administration (SAMHSA) OTPs must be reaccredited and recertified every 3 years

Distribution of Controlled Substances by Pharmacies - the 5% rule

On occasion, a pharmacy may wish to distribute controlled substances from one registrant to another (e.g. a nearby pharmacy runs out of a CS medication, so you sell them some from your own stock). Pharmacies may distribute controlled substances without being registered for this activity if the following are met: 1. The registrant to whom the drug is being distributed is registered to dispense (DEA dispensing registration) 2. The distribution is recorded with the proper information for both the distributor and recipient (If the drug is a C‐II, DEA Form 222 is executed) Drug name, strength, dosage form, and quantity Number of commercial containers distributed Date distributed (seller) Date of receipt (purchaser) Name, address and DEA number of the pharmacy or practitioner to whom it was distributed 3. The total number of dosage units distributed does not exceed 5% of the total number of CS dispensed and distributed in 1 calendar year (21 CFR 1307.11)

CIII-CV Prescription Orders

Oral telephone orders are allowed for CIII - CV prescription orders. Thus, if a pharmacist has questions on a CIII - CV prescription order, they may call the prescriber and either change information per consultation with the prescriber or take a new telephone prescription order from the prescriber and void the original prescription order received.

Training/Education Requirements for Pharmacists to Dispense an Opioid Antagonist without a prescription order

Pharmacist shall complete an opioid prevention and treatment training program that includes the following information: How to recognize the symptoms of an opioid‐related overdose, How to respond to a suspected opioid‐related overdose, How to administer all preparations of an opioid antagonist, and The information need by an individual to whom an opioid antagonist is dispensed, and Comply fully with policies and procedures

Dispensing Controlled Substances - who is allowed to dispense CS prescriptions

Pharmacists Registered individually Employed by a registered pharmacy Employed by a registered institutional practitioner Individual Practitioner If authorized by state law ~ office dispensing Opioid Epidemic Act: A prescriber who treats humans is PROHIBITED from dispensing from their office any CII opioid prescription medications o Exemption - implantable devices (MD, DO, PA, RNP, Certified Nurse Midwife) Veterinarians are allowed to dispense CII opioids from their office practices.

Issues for pharmacies and pharmacists

Pharmacists and pharmacies that compound, repackage, or re‐label controlled substances need to be aware that the DEA views this differently than the FDA. FDA in general allows pharmacies to compound DEA rules (21 CFR 1301.13 (e) (l)(iii)) allow pharmacies to compound controlled substances as long as the final product does not have more than 20% of a narcotic substance. DEA definition of compounding (dispensing) and manufacturing is different from the FDA if for office use or administration by prescriber to patient. o DEA views compounding of controlled substances for "office use" or for administration by the prescriber as DISTRIBUTING and not dispensing.

DISPENSING NALOXONE WITHOUT A PRESCRIPTION ORDER FROM A PRESCRIBER OR BASED ON THE PUBLIC HEALTH STANDING ORDER

Pharmacists may dispense without a prescription order, based on protocols developed by the ASBP, naloxone HCL or any other opioid antagonist that is approved by the US FDA. Recipients may be: Any person who is at risk of experiencing an opioid‐related overdose, or To a family member, or To a community member who is in a position to assist that person. Community member includes: emergency first responders, peace officers or other law enforcement, fire department personnel, school district employees, and/or personnel of a facility or center that provides services to individuals at risk of experiencing opioid‐related overdose.

Institutional Pharmacies

Prescribers in an institutional setting write medication orders for inpatients, not prescription orders. Since medication orders are not prescription orders, they do not have to meet the same legal requirements. Institutions must still maintain acceptable records of dispersal and make them readily retrievable.

maximum number of patients allows to treat

Qualifying MDs/DOs 30 to 100 to 275 Qualifying PAs/Nps 30 to 30 to 30 Only these drugs and their therapeutic equivalents are allowed under DATA - Probuphine (REMS - closed‐system), Suboxone, Subutex, and Zubsolv

Retail sale of ephedrine, PSE, and PPA (federal and state)

Requirements -purchaser must present valid photo ID -product must be stored behind the counter or in a locked cabinet Quantity Limits (Federal) -no more than 3.6g of each purchased by the same individual on any given day if obtained via shipping -no more than 7.5g of each purchased by the same individual in any given 30 day period otherwise.. no more than 9g of each purchased by the same individual in any given 30-day period

Sale of Non-Prescription C-V substances

Schedule V substances may be purchased without a prescription. However, there are some special requirements for dispensing: 1. Only a pharmacist (or intern) may dispense non‐prescription C‐V products 2. Purchaser must be at least 18 years of age If purchaser not known by the pharmacist, must furnish suitable identification 3. There are limitations on the quantity that can be purchased by a single person... No more than 240 ml (8 oz.) or 48 dosage units of an opium‐containing controlled substance may be dispensed at retail to the same purchaser with any given 48‐hour period No more than 120 ml (4 oz.) or 24 dosage units of any other controlled substance may be dispensed at retail to the same purchaser within any given 48‐hour period No more than 100 dosage units of any single active ingredient ephedrine preparation may be dispensed to the same purchaser in any given 30‐day period (AZ) 4. Sale must be recorded in a bound record book showing: Name and address of purchaser Date of sale Name and quantity of product sold Name of dispensing pharmacist Report any unusual sales to the Board of Pharmacy!

electronic imaging recordkeeping system

Some pharmacies have the capability of scanning and saving the image of the original prescription. The prescription image and all associated annotations must be maintained for 7 years from the date last dispensed The original hard copy must be maintained for at least 30 days Not allowed for C‐II prescriptions

DEA inspections

The DEA may enter and inspect any place where controlled substance or their records are kept or where persons are registered under the CSA Upon inspect, a DEA agent/inspector is REQUIRED to: Present owner or pharmacist with agent's credentials Present written notice of inspection State the purpose of the inspection Obtain written statement of informed consent to the search, signed by the owner or PIC Unless consented to in writing by the owner or PIC, agents are PROHIBITED from inspecting: Financial data Sales data, other than shipment data Pricing data To avoid the consent requirement, a DEA agent/inspector may obtain an Administrative Inspection Warrant (AIW) Registrants may not refuse an Administrative Inspection Warrant

Mailing controlled substances

The U.S. Postal Service does allow controlled substances to be mailed, but packages must meet the following requirement: The inner container of any parcel containing controlled substances must be marked and sealed pursuant to any relevant provisions in the CSA and its regulations, and placed in a plain outer container or securely wrapped in plain paper. If the controlled substances consist of prescription medicines, the inner container must also be labeled to show the name and address of the pharmacy practitioner, or other person dispensing the prescription. The outside wrapper or container must be free of markings that would indicate the nature of the contents.

Disposal or Destruction of Controlled Substances

There are 4 methods allowed by the DEA 1. Transfer the items to a 'reverse distributor' registered with the DEA (This is the DEA‐preferred method) Requires an invoice for C‐III - C‐V drugs or a DEA Form 222 for C‐II drugs Can be done at any time 2. Request DEA authorization to destroy the items on site Requires submitting DEA Form 41 Allowed once per calendar year 3. Send the items to the nearest DEA agent or facility (Uncommon) 4. By other means as authorized by the DEA Request a "blanket authorization" to destroy CS items at any time (Usually reserved for institutions that need to dispose of injectables)

Divided into 3 Titles

Tital I - rehabilitation program for drug abuses Title II - registration and distribution of controlled substances Title III - import and export regulations for controlled substances

faxed C-II prescriptions

Under normal circumstances, a faxed C‐II order allows the pharmacist to beginning filling. However, the pharmacist must receive the original hardcopy before releasing the CS medication from the pharmacy.

manufacturer labeling and packaging of controlled substances

all commercial containers of a controlled substance drug must be labeled with identification symbols showing the schedule in which the drug is placed

a faxed C-II prescription may serve as the original hardcopy when

any location of patient • CII narcotic for a compounded injectable solution (parenteral, IV, IM, SQ, or intraspinal) and will be directly administered to patient in any setting LTCF • CII narcotic for a compounded injectable solution (parenteral, IV, IM, SQ, or intraspinal) and will be directly administered to patient in any setting • Any CII for a resident of LTCF (long‐term care facility) Hospice (in-patient or out-patient) • CII narcotic issued for patient enrolled in Medicare certified hospice care program

authority for scheduling - state level - arizona

arizona state legislature -changes to the uniform controlled substances act (AZ) are done through the legislative process

Treatment of pain

chronic use of opioids can build drug tolerance and a physical dependence, so dosing, strength, or refill frequency alone is not proof of fraud or abuse. Base your decision to dispense on patient safety, not liability. be aware that there are state and national initiatives and guidelines that have been developed that address the treatment of non-malignant chronic pain

DEA number

dispensing registrants: A, B, F, or G midlevel practioner = M 1) add first, third, and fifth digits 2) add second, fourth, six digits and multiply by 2 3) add the two sums together 4) the last digit of the summed total, last digit of the DEA #

what do I need to include on my CS inventory?

drug name, strength, form, and most importantly quantity C‐II drugs require EXACT counts C‐III - C‐V drugs in containers of > 1000 dosage units require EXACT counts C‐III - C‐V drugs in containers of ≤ 1000 dosage units may be estimated

Laws - Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 aka Controlled Substances Act (CSA)

establishes a "closed system" for manufacturing, distribution, and dispensing of controlled substances -"closed system" - meaning that only persons registered with the DEA are allowed to engage in these activities

ordering controlled substances - aka "record of receipt"

general information on recordkeeping keys to compliance with CSA: -know the law -document completely -keep record readily retrievable violations can result in fines up to 10,000 per incident (even if unintentional)

Who must register with the DEA? -individual practitioners

generally have CII-CV dispensing registration required if the practioner prescribes, orders, or dispenses any CS if a prescriber has multiple offices and dispenses from each of those offices - each location must have a separate DEA registration requires renewal every 3 years

storing controlled substances

in a securely locked substantionally constructed cabinet dispersed throughout the stock of unscheduled medications

General Treatment

initial prescription for a CII opioid = 5 day supply limit definition of initial prescription Initial fill is defined as not previously received by the patient within 60 days of the pharmacy filling the current prescription exemption to the initial prescription supply limitation Active oncology diagnosis Traumatic injury, excluding surgical procedure Receiving hospice care, end‐of‐life care, palliative care, treatment for burns, or skilled nursing care Receiving medication‐ assisted treatment (MAT) for a substance abuse disorder; or Infant being weaned off opioids at the time of hospital discharge dosing limitation Rx dosing cannot exceed 90 morphine milligram equivalents (MME)/day Exception: prescriber may issue RX for more than 90 MME/day if a consulting physician, board‐certified in pain or opioid call service agrees with the higher dosage. Exempts prescribers who are board‐certified pain specialists from consultation requirements. exceptions to the 90 MME dosing limitation Rx is continuation of a prior Rx issued within the previous 60 days An opioid with a maximum approved daily dose in the FDA approved labeling Patient with an active oncology diagnosis or traumatic injury, not including a surgical procedure Patient who is hospitalized Patient receiving hospice care, end‐of‐life care, palliative care, skilled nursing facility care, or treatment for burns Patient receiving medication‐assisted treatment (MAT) for a substance abuse disorder naloxone or another opioid antagonist Co‐prescribed to any patient receiving more than 90 MMEs/day

FDA approved drugs for treatment of opioid addiction - CII

methadone (C-II) LAAM (C-II) Methadone and LAAM cannot be prescribed for "maintenance" or "detoxification" outside of an OTP and cannot be dispensed by a community pharmacy for OTP patients. Methadone may be prescribed in the in‐patient or out‐patient setting for the treatment of pain.

Additional labeling for CII opioids (AZ specific)

must be dispensed with a red cap and a warning label

Partial Filling of CS prescriptions

occassionally will want you to fill a portion of the prescribed quantity of medication (usually due to cost or estimated length of therapy) All CS prescriptions may be partially filled, however C-II prescriptions have some special requirements and exceptions... -may not exceed the total number of dosage units prescribed over the life of the prescription order

authority for scheduling - federal level

scheduling authority is given to the US Attorney General -the US attorney general delgates this task to the DEA prior to scheduling, the Secretary of the Department of Health and Human services must perform a medical evaluation of the drug and makes its recommendation -the secretary of DHHS delegates this task to the Food and Drug administration

additional information required for oral prescription (AZ)

telephone number of prescriber

who can sign DEA form 222?

the DEA registrant OR whoever has been granted power of attorney

recordkeeping

the following information must be recorded for each sale The following warning statement: WARNING: Section 1001 of Title 18, United States Code, states that whoever, with respect to the logbook, knowingly and willfully falsifies, conceals, or covers up by any trick, scheme, or device a material fact, or makes any materially false, fictitious, or fraudulent statement or representation, or makes or uses any false writing or document knowing the same to contain any materially false, fictitious, or fraudulent statement or entry, shall be fined not more than $250,000 if an individual or $500,000 if an organization, imprisoned not more than five years, or both. Date and time of sale Drug name Quantity Name and address of purchaser DOB of purchaser (Phoenix ordinance) Purchaser ID type and number Signature of purchaser Information may be recorded in a log book or electronically Information may be recorded by either the seller or purchaser, but one must verify what the other has entered Maintain logbook for at least 2 years from the date of last sale.

Organization and storage of CS prescription

the original of every prescription order must be serially numbered, dated, and filed in the order in which the drugs were compounded or dispensed

Receiving CIIs orders and completing DEA form 222 at your pharmacy (aka closing the loop)

upon receipt of CII drug products, the following items must be documented on Copy 3 (blue/bottom): 1. Number of containers received for each line item ordered 2. Date containers received. if the supplier partially fills the order, the supplier has 60 days from the date of execution of DEA form 222 to supply the balance. After 60 days of date of execution - the order form becomes invalid

The Federal CS Scheduling Process

ways a drug may become a controlled substance: 1. step 1: scheduling change (scheduling, rescheduling, or unscheduling) may be initiated by DEA, FDA, Congress, or petition 2. step 2: FDA/DHHS performs a medical evaluation of the drug (mostly related to abuse potential) and makes a recommendation to the DEA -if the recommendation from the FDA is that a drug not be controlled, the DEA must comply 3. Step 3: DEA proposes the change and provides opportunity for public comment (Federal Register) 4. Step 4: Then the DEA, by rule, may make the proposed change (Final rule published in Federal Register with time frame for effective date and archived in CFR) exception: The DEA can place a drug into schedule I without consulting DHHS if there is "imminent hazard to the public safety"

inventory of controlled substances

when do I need to take inventory of my CS stock? arizona law requires inventory every year on May 1st (federal requirement is only every 2 years after the initial inventory)