Arizona Uniform Controlled Substances Act

What is the uniform controlled substance act and who drafted it?

Drafted by the uniform law commission

Basis for narcotic and dangerous drug law in 46 states and jurisdictions

What does "the board" refer to?

Arizona State Board of Pharmacy

What does "the department" refer to?

Department of Public Safety (DPS)

What is the DEA?

Drug Enforcement Administration

Is marijuana and cannibis scheduled in AZ?

Marijuana is not in schedule I

Cannabis is scheduled Arizona

Is ephedrine scheduled in AZ?

Yes; C-V

Who must register for a state license with the State Board?

Any medical practitioner, pharmacy, pharmacist, manufacturer, or wholesaler

Registrant under federal controlled substances act (ex. Pharmacies must have a DEA registration)

Who does not need to register for a state license with the State Board?

Patients (end-users)

Pharmacists working individually (unless working under a collaborative practice agreement/independent prescriber authority)

Delivery/warehouse workers

Officers/employees of DPS

How long must inventory records be kept for in AZ?

3 years

When does AZ require an inventory of controlled substances?

Annual inventory on May 1 of each year or as directed by the board

When specific circumstances would inventory of controlled substances be required in AZ?

Opening a new pharmacy

When there is a change of ownership or d/c of business

If CS stock is taken from closing pharmacy

Within ten days of a change in PIC

If state board directs you to

What are the regulations for inventory of a C-II?

must include exact count of all C-II

What are the regulations of inventory for C-III, C-IV, and C-V?

Exact count or estimated IF stock container contains less than 1001 units

What needs to be included when recording inventory?

Date of inventory

Whether it was taken before opening or closing

Signature of PIC

A loss of a controlled substance shall be reported to the State Board within

10 days of discovery

What form should be submitted to the DEA for loss of a controlled substance and who should report this?

PIC or manufacturer should report this on DEA form 106

A loss of controlled substance should be submitted to the FEDERAL DEA, Narcotic Division of DPS, and Board of Pharmacy within

1 day + copy of DEA form 106 shall be kept on file by pharmacy permittee and shall state whether police reported loss

Every person receiving, selling, delivering, or disposing of any controlled substance shall record and retain what for at least 3 years?

Name, strength, dose, quantity for each controlled drug

Name, address, DEA # of the person who gave it away

The name, address, and DEA # of person who received it

The date of each transaction

Controlled substances in Schedule I and II shall be distributed to another registrant only pursuant to what form?

Order form (specifically DEA form 222)

When a pharmacy is discontinued, what should be returned to the DEA Regional Office?

Schedule II order forms

When should a full service drug wholesaler permittee or designated representative complete and inventory controlled substances?

On may 1 of each year

If there is a change in ownership or d/c of business

Or within 10 days of a change of a designated representative

What must happen when a pharmacy is discontinued?

Schedule II order forms (222) are to be returned to the DEA Regional Office

What should a prescription order contain?

Date issued

name address for person or owner of animal for which drug is ordered

Refills authorized

Name, address, and telephone number of prescribing medical practitioner

Name, strength, dosage form, quantity of drug ordered

Directions for use

If written, wet/manual signature of prescriber

Controlled substances must also require:

DEA registration number of prescriber

Only one drug order per prescription blank

A prescription label must include:

Date of issuance

Name and address of patient for whom or owner of animal for which drug or device is dispensed

Drug name, strength, dosage form, device name

Name of drug's manufacturer or distributor

Prescribing medical practitioner's directions for use

Date of dispensing

Quantity prescribed and if different, quantity dispensed

Medical practitioner's address and DEA number (if controlled substance)

Written: medical prescriber's signature

Electronically transmitted: medical practitioner's digital or electronic signature

name/initials of dispensing pharmacist

If authorized verbally by the prescriber, the pharmacist may make changes to a written or electronic C-II EXCEPT:

The patient's name

The prescribers name

The drug name

A prescription for a schedule II substance shall not be dispensed more than

90 days after the date on which the prescription order was issued and CANNOT be refilled

If a pharmacist makes changes to an original prescription order (except what was listed before) what must happen?

Must document original prescription order

Document the change that were made pursuant to verbal authorization

Record the time and date the authorization was granted

All CII opioid prescriptions may ONLY be dispensed with what?

An electronic prescription order

What are exceptions to electronic C-II opioid prescribing requirements?

System not operational

Prescription not licensed in this state (but another state)

Medication that requires compounding two or more ingredients

Written for detained individual or in custody of AZ or federal law enforcement

VA facility, health facility on a military base, IHS hospital or facility, or tribal-owned clinic (they use their government-ID license/number)

Initial prescriptions for a schedule II opioid must be written for a supply of:

Five-day supply EXCEPT following a surgical procedure (14-day supply)

A new prescription for a schedule II opioid can't exceed

90MMEs per day EXCEPT if hospitalization/surgical procedure

What is the role of the pharmacist under Arizona's Opioid Epidemic Act?

Pharmacist not required to verify with prescriber whether initial prescription complies with this section or that prescription meets 90 MME per day

If a patient is prescribed more than 90 MME per day, the prescriber shall also prescribe

Naloxone hydrochloride or any other opioid antagonist that is approved by USFDA for opioid-related overdoses

hat are patient exceptions under the Arizona Opioid Epidemic Act?

Active oncology diagnosis

Traumatic injury

Hospice care

End-of-life care

Palliative care

Skilled nursing facility care

Burns

Medication-assisted treatment for a substance use disorder

Infant being weaned off opioids at time of hospital discharge

In an emergency, can emergency quantities of schedule II substances be dispensed on an oral prescription order?

Yes IF:

Immediately reduced to writing

Within 7 days after the prescribing medical practitioner gives written prescription

It has "authorization for emergency dispensing" on its face

What happens if a the prescribing medical practitioner fails to deliver an emergency prescription order within 7 days

The pharmacists must notify the board within 7 days

What may be transmitted to a pharmacy by fax by a patient's medical practitioner or practitioner's agent and are considered the original prescription for record keeping purposes?

Schedule II to be compounded for direct administrative to a patient by parenteral intravenous, intramuscular, subcutaneous or intraspinal infusion

Schedule II prescription written for resident of LTCF

Schedule II prescription written for patient enrolled in hospice

A controlled substance included in schedule II or IV requires a prescription order that shall not be dispensed without...?

A written or oral prescription order of a medical practitioner

How long after the prescription order was issued can a C-III or C-IV be filled or refilled?

6 months and no more than 5 refills

How many refills are allowed for a prescription order for a schedule III or IV?

Shall not be refilled more than 5 times

How could someone get more refills for a schedule III or IV?

Additional quantities may only be authorized by the doctor through a new prescription order

A Schedule V controlled substance may be dispensed under:

Written or oral prescription order of a medical practitioner

A Schedule V controlled substance may be filled/refilled after how long after issuance?

As authorized by prescribing medical practitioner but shall not be filled or refilled more than one year after the date of issuance

The label on a container of a controlled substance that is dispensed by a medical practitioner or pharmacist that is not for immediate administration must bear what?

Name and address of the dispensing medical practitioner or pharmacist

The serial number

The date of dispensing

Name of prescriber

Name of patient or animal (& owners name and species)

Directions for use and cautionary statements

If the controlled substance is included in schedule II, III or IV, the label shall bear a transfer warning to the effect of ...?

Caution: federal law prohibits the transfer of this drug to any person other than to whom it was prescribed to

What kind of cap is required on a schedule II controlled substance dispensed that is not for immediate administration to the ultimate user?

Red

A Schedule III, IV, or V prescription can be faxed to what pharmacy?

To pharmacy of patient's choice

The faxed prescription order of a Schedule III, IV, or V controlled substance must contain:

All information required for a prescription order

Date prescription order is faxed

Fax number of prescriber and telephone number of facility

Name of person who transmitting fax

The faxed prescription order of a Schedule III, IV, or V controlled substance must be faxed from

Medical practitioner's practice location, except that a nurse in a hospital, long-term care facility, or inpatient hospice may send fax of a prescription order for a patient of the facility

How long should pharmacies retain prescription records and how does this relate to faxes?

7 years; can store a photocopy of the fax

What are exceptions to electronic prescribing requirements?

Medical practitioners may use written prescription when:

Prescribed from another state

For medication that requires compounding of 2 or more ingredients

For medication not in e-prescribing database

Is written for individual who is detained by or in custody of AZ or federal law enforcement

What is required for a transfer from out of state?

Must be between two pharmacists or interns

The following info is recorded by the receiving pharmacists

"Transfer" on it

Date of issuance of original order

Original # of refills

Date of original dispensing

Number of valid refills

Name, address, DEA #, original prescription # of pharmacy

Name of transferring pharmacists

Name of receiving pharmacists

What should be maintained in a separate prescription file for controlled substances?

-Schedules I and II must be maintained in a separate prescription file for controlled substances listed in schedules I and II only

-Schedules III, IV, and V must be maintained either in a separate prescription file OR in a form that allows them to be readily retrievable from other prescription records of registrant

What is required of every prescription order of drugs, devices, or replacement soft contact lenses that are compounded or dispensed at the pharmacy records?

Serial #, date and filed in order in which the things were compounded or dispensed

Kept for at least 7 years!

What can a judge of a state court of record with probable cause do?

Issue warrants for the purpose of conducting administration inspections and seizures of property appropriate to the inspection

What is required of a warrant from a judge?

Grounds for issuance

Be directed to a peace officer to execute

Command the person to whom it is directed to inspect the area

Identify the item or type or property to be seized

Direct that it be served during normal business hours

Designate the judge to whom it shall be returned

How many days must a warrant be executed and returned from its date of issuance?

10 days

What is "controlled premises"?

-Places where persons registered or exempted from registration requirements under this chapter are required to keep records

-Places including factories, warehouses, establishments, and conveyances in which persons registered or exempted from registration requirements under this chapter are permitted to hold, manufacture, compound, process, sell, deliver, or otherwise dispose of any controlled substance

True or false: the board, its members, officers, or employees and officers of the department or other peace officers may make administrative inspections of controlled premises.

True

What constitutes ARS 36-2542 (cooperation)?

-State board cooperates with federal and other state agencies in discharging responsibility concerning traffic in controlled substances and in suppressing abuse of controlled substances

-Includes notifying law enforcement agencies relating to any person known to have violated or who is suspected of violating AZ CSA to obtain controlled substance

Within how many days must a pharmacy permit or PIC provide written notice to the Board and DEA before discontinuing operation of a pharmacy?

14 days

What must the pharmacy committee or PIC ensure before discontinuation of a pharmacy?

That all DEA registration certificates and DEA schedule II order forms are returned to the DEA regional office in Phoenix

What is not stocked in an automated dispensing system?

C-II drugs

Controlled substances contained in automated dispensing system are still included in inventories and remain the property of?

the pharmacy

What is required for each location of a LTCF where automated dispensing systems containing CS are located?

Separate controlled substance registrations

In regards to the emergency drug supply unit, what does the limited service pharmacy permit or PIC of a provider pharmacy need to ensure?

-That an emergency drug supply until is available within the LTCF

-Drugs contained in an emergency drug supply until remain the property of the provider pharmacy and controlled substance drugs contained in an emergency supply until are included in all inventories

In terms of emergency drug supply units, drug removal procedures require that...?

The LTCF personnel receive a valid prescription order for each

Drug removed from the emergency drug supply unit

The LTCF personnel notify the provider pharmacy when a drug is removed from the emergency drug supply unit

Outdated drug replacement procedures

Security and inspection procedures

What does the pharmacy permittee or PIC need to notify the board of in regards to the emergency drug supply unit?

Needs IN WRITING of the intent to used an automated emergency durg supply unit including the name and type of unit