Controlled Substances

Logbook method for electronic RF documentation

Bound logbook or separate file Each individual pharmacist signs a statement verifying the prescriptions that the pharmacist refilled Maintained for 2 years

WI law permits this sort sorting of files, however it is not recommended

CII may be filed with those for CIII-CV drugs provided all orders in the file for schedule III, IV and V drugs are stamped in red ink with the letter "C"

Pseudophedrine class

CV

Then the purchaser submits the following DEA 222 forms to the supplier

Copy 1 and 2 original copy

prescription orders issued by advanced practice nurse prescribers for a controlled substance shall be written in ink or indelible pencil or shall be submitted electronically as permitted by state and federal law, and shall contain the practitioner's (2)

DEA # Certification #

When you distribute schedule II drugs to a reverse distributor or a wholesaler/manufacturer as a return, use

DEA form 222

The registrant destroying the controlled substances documents this on

DEA form 41

When transferring schedule III-V, you must include

DEA number (WI DEA number and telephone number of pharmacy)

Information pertaining to current prescription orders for schedule II controlled substances for patients in an LTCF or for patients with a medical diagnosis documenting a terminal illness may be maintained in a computerized system if the system has the capability to permit (per WI)

Display or printout of: the original prescription order designation; date of issue; identification of prescribing practitioner; identification of patient; name and address of the LTCF or name and address of the hospital or residence of the patient; identification of medication authorized, including dosage form, strength and quantity; listing of partial quantities that have been dispensed under each prescription order (Address is a key difference in WI law)

Partial fills for LTCF or terminal illness

For patients in a LTCF or with a terminal illness, schedule II prescriptions may be partially filled to allow for the dispensing of individual dosage units. Partial fills are permitted no longer than 60 days from the date of issuance. The total quantity of drug dispensed in all partial fillings must not exceed the quantity prescribed. The pharmacist must record on the prescription whether the patient is "terminally ill" or an "LTCF patient."

printout method for electronic RF documentation

Hard copy printout of each day's refills•Provided to the pharmacy within 72 hours of the date the refill was dispensed Verified, dated, and signed by each pharmacist who refilled the prescriptions listed on the printout Maintained for 2 years from the dispensing date

Labeling Exemption for Institutionalized Patients

If the drug is in schedule II, no more than a 7‐day supply is dispensed at one time. If the drug is in schedule III, IV or V, no more than a 34‐day supply or 100 dosage units (whichever is less) is dispensed at one time. The drug is not in possession of the ultimate user before administration. The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the drug. The system used by the pharmacist in filling the prescription is adequate to identify the supplier, the product, and the patient, and to state the directions for use and cautionary statements.

An emergency situation is defined as a situation in which

Immediate administration of the controlled substance is necessary for the proper treatment of the patient No appropriate alternative treatment is available It is not reasonably possible for the prescribing physician to provide a written prescription to the pharmacist before dispensing

DEA‐approved procedure for using the emergency kit

LTCF notifies the prescriber the resident needs something from the kit Prescriber issues a prescription to the pharmacy Pharmacist authorizes the LTCF nurse to dispense the medication from the kit

Maintain records for at least ___ years at the place of registration. Executed order forms (unless maintained electronically), inventory records, and paper prescriptions cannot be maintained centrally but rather must be maintained at ___________

Maintain for 2 years maintain at location of registration

APNP's may not prescribe the following (3)

May not issue a prescription order for any schedule I controlled substance. May not prescribe, dispense or administer any amphetamine, sympathomimetic amine drug or compound designated as a schedule II controlled substance (with exceptions) may not prescribe, order, dispense or administer any anabolic steroid for the purpose of enhancing athletic performance or for other nonmedical purpose

The label of the dispensed drug must contain (from a central fill pharmacy)

Must contain central fill pharmacy's DEA # indicating that the prescription was filled at the central fill pharmacy.

Total qty limited to ____ days for latter Rx orders

NMT 90 days

Do Schedule V have RF limits

No

For CII Rx, there are no federal limits on these 2 things

No federal time limit for filling the prescription after signed by the practitioner No federal limit on quantity (likely limited by insurance coverage and/or state law)

Transferring schedule III-V

Pharmacies may transfer information between themselves for refill purposes for schedule III, IV, and V prescriptions on a ONE TIME basis only, if state law allows it. However, pharmacies that electronically share a real‐time online database are allowed to transfer back and forth up to the maximum refills permitted by law and the prescriber's authorization. A transfer can take place only by means of direct communication between two licensed pharmacists.

Electronic transmission fail

Prescriber may print a copy of the transmitted prescription and sign it Copy must indicate it was originally transmitted to a specific pharmacy and the transmission failed Pharmacy receiving paper copy must check to ensure the e‐prescription was not received or dispensed

The CSA requires that every registrant keep these 3 records

Records of inventory Records of drugs received Records of drugs dispersed

identification cards are also required for these schedule drugs

Schedule II or III (record name of person picking up if not patient)

What must be noted on Rx if CII is for hospice

That the patient is a hospice patient

Recording Partial Fills of Schedule II Prescriptions

The date The quantity dispensed The remaining quantity authorized to be dispensed The identification of the dispensing pharmacist

WI distribution to other registrant for CIII-CV must include

The date distributed The name, address, and registration number of the person to whom the containers were distributed *These are notably different than fed law*

Labeling of Scheduled Drugs

The label of a controlled substance must include the following: Date of filling (schedule II) or initial filling (schedule III, IV, or V) Pharmacy name and address Serial number of the prescription Name of the patient Name of the prescriber Directions for use and cautionary statements, if any For schedule II, III, and IV drugs: "CAUTION: Federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed."

WI is less strict on CII Rx orders that are faxed. For example

The prescription order is written for a schedule II controlled substance for a patient who resides in a long term care facility, or who meets the eligibility requirements for placement in a long term care facility but elects to reside at home, and is transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. •(c)The prescription order is written for a schedule II controlled substance for a patient enrolled in a hospice certified by medicare under Title XVIII or licensed by this state, and is transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile (hospice = any CII)

DEA form 222 lost or stolen outside of transmission

The purchaser or supplier must immediately notify the DEA and provide the serial number of each missing form

The dispensing of schedule V substances is subject to the following conditions (WI)

They may be sold at retail only by a pharmacist or, if the substance is a pseudoephedrine product, by a person who is working under the direction of a pharmacist when sold in a retail establishment. When sold in a retail establishment, they shall bear the name and address of the establishment on container

Partial fill (inability to supply)

Unable to supply" has been interpreted by the DEA as insufficient stock on hand, as well as waiting to verify the legitimacy of a prescription, patient unable to afford, or patient did not want the full quantity. The pharmacist is required to note the quantity supplied on the face of the prescription and provide the balance of the prescription amount within 72 hours after the partial filling. If the pharmacist is unable to supply the remaining quantity within 72 hours, the pharmacist must notify the prescriber and no further quantity may be supplied beyond 72 hours without a new prescription.

When are faxed CII Rx allowed

a narcotic schedule II substance to be compounded for direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion a resident of a long‐term care facility patient enrolled in a hospice care program certified by/or paid for by Medicare under Title XVIII, or licensed by the state. The practitioner or agent must note on the prescription that the patient is a hospice patient

Individual practitioners must store scheduled drugs in

a securely locked, substantially constructed cabinet

Individual practitioners may _____ or _______ a schedule III, IV, or V substance in the course of professional practice without a prescription.

administer or dispense

A pharmacist may dispense a controlled substance listed in schedule II, III or IV only pursuant to a prescription order issued by

an individual practitioner (PA or physician). Does not include optometrist or APNP

Note exceptions for fax LTCF can be for

any CII Hospice is only for CII narcotics

Any person purchasing such a substance that is a pseudoephedrine product shall.

at the time of purchase, present to the seller that person's correct name, address, and an identification card containing the person's photograph. The seller shall record the name, date of birth, and address of the purchaser; the name and quantity measured in grams of pseudoephedrine contained in the product purchased; the date and time purchased; the purchaser identification type and number, such as driver's license state and number; and the name of the seller or, if the pseudoephedrine product is being sold by a person who is not a pharmacist, the name of the pharmacist supervising the seller. The purchaser shall sign the record of the transaction.

The______ inventory record for each controlled substance must include

biannual the date, whether taken at the beginning or close of business, the name of the substance, dosage form, strength, number of units or volume in each container, and number of containers, and count

The pharmacist is never permitted to make these changes on a CS Rx

changes to the patient's name, controlled substance prescribed (except for generic substitution), or the prescriber's signature

the purchaser keeps the following DEA 222 forms

copy 3 copy of the org

Under the statute and the regulations, individual practitioners must keep records of the controlled substances that they _______ but not _______

dispensed but not prescribed

a seller shall _________________ submit records of pseudoephedrine sales to the system __________ completing a sale of a nonprescription pseudoephedrine product.

electronically, before sale

type of count permissible for CIII-CV

estimated count (unless container holds more than 1000 units)

If prescriber initial authorized fewer than 5 RF for schedule III-IV may authorize

further RFs without renewing Rx Qty can not exceed initial (it is equal to or less)

Federal PSE record keeping

must be recorded in a written or electronic logbook that identifies the product by name, the quantity sold, the name and address of the purchaser, and the date and time of the sale. The purchaser must sign the logbook. Either the seller or purchaser may enter the purchaser's name, address, and date and time of sale. The signature may be collected by signing an electronic device, signing a bound paper book that permits the signature to be linked back to the logbook entry, or signing a document that the seller prints at the time of sale displaying the required logbook information. The log must warn the purchaser of misrepresentation and include the maximum fine and term of imprisonment for misrepresentation. The log book must be maintained for 2 years after the last entry

is ephedrine scheduled in WI

no it is not CV, but have to follow federal regulations

Electronic copies of DEA Form 222 may be stored

on a system at a location different from the registered location, provided such copies are readily retrievable at the registered location.

Any theft or loss of any controlled substance must be reported to the DEA in writing within ____ business day of discovery

one

Notify DEA and local police within _____ business day of discovery

one business day and shall be notified in writing

What types of Rx are permitted in an emergency situation

oral or faxed authorization

WI must dispense CS to whom

patient or a member of patient's household (to anyone else is considered distribution, not required per federal) Identification card

An authorized agent of a physician at the LTCF is permitted to

prepare a written prescription for the signature of the practitioner convey orally to a pharmacy prescription orders from a practitioner for schedule III‐V drugs (but never schedule II) transmit a fax prescription from the prescriber (which does include schedule II prescriptions)

An advanced practice nurse certified may dispense a controlled substance only by

prescribing or administering the controlled substance

For a schedule II controlled substance prescription order, a pharmacist may add, modify or clarify the (per WI)

registration number of the practitioner, and the address of the practitioner and the patient if that information is verifiable and retrievable from information maintained by the pharmacist or is obtained through consultation with the practitioner.

CII records must be mainted

separately from all other orders

person knowingly filling such a purported prescription, as well as the person issuing it, shall be

subject to the penalties provided for violations of the provisions of law. BUT UNKNOWINGLY, THEY ARE NOT SUBJECT PENALTIES

An advanced practice nurse certified under s.441.16shall include with each prescription order

the advanced practice nurse prescriber certification number

If e‐prescription received but not dispensed

the e‐prescription must be voided

If e‐prescription dispensed

the paper prescription must be voided

WI law does not require this on CS labels (however we have to follow stricter federal law)

they only require date of dispensing, federal law requires initial date of filling and dispensing date

If the person accepting the medication pursuant to any prescription order for a schedule II controlled substance is not personally known to the pharmacist, there shall

written in ink, on the reverse side, the printed name, signature and address of the person. (written okay to be electronic per federal)

Does WI match Federal for requirements of CS Rx

yes, however no mention of special requirements, follow federal requirements

Special requirements for CS Rx

•DATA 2000 waiver ID or "X" number •Medical need of the patient for GHB prescriptions

Exceptions of Treatment vs addiction

•DATA waiver (CIII-CV) •Prescriber administration (not to prescribe) from office supply for maximum of 3 days (NMT 1 day treatment at a time) •Physician or authorized hospital staff member administration or dispensing of narcotic drugs to maintain or detoxify a hospitalized patient incidental to treating a condition OTHER than the addiction (continue maintenance tx)

General requirements for CS Rx

•Date of Issuance •The full name and address of the patient •The name, address, and registration number of the practitioner •The drug name, strength, dosage form •The quantity prescribed •Directions for use •Signature of practitioner (unless oral prescription)

The DEA permits the issuance of multiple prescriptions subject to the following restrictions

•Each prescription must be issued on a separate prescription blank •The total quantity prescribed cannot exceed a 90‐day supply •The practitioner must determine there is a legitimate medical purpose for each prescription and be acting in the usual course of professional practice •The practitioner must write instructions on each prescription (other than the first) as to the earliest date on which the prescription may be dispensed •The practitioner concludes that the multiple prescriptions do not create an undue risk of diversion or abuse •The issuance of multiple prescriptions must be permissible under state law •The practitioner must comply fully with all other CSA and state law requirements

Federal methamphetamine act

•Regulates the OTC sale of any product containing ephedrine, pseudoephedrine (PSE), or phenylpropanolamine (PPA) -these are all considered scheduled listed chemical products (SLCP) •A regulated seller may not sell OTC more than 3.6 g of ephedrine base, PSE base, or PPA base to a single purchaser per day, regardless of the number of transactions. •No consumer may purchase more than 9 g of the listed products within a 30‐day period or 7.5 g within a 30‐day period if purchased by mail order. •Generally, all non‐liquid forms of the products must be sold in 2‐unit blister packs or unit dose packaging. •The products must be stored behind the counter or in a locked cabinet in an area where customers do not have direct access.

After consultation with the prescribing practitioner, a pharmacist may add, modify or clarify the (per WI for CII)

•Strength •dosage form •quantity prescribed •date of issuance •directions for use for a schedule II controlled substance prescription order

Schedule III-V invoices require

•The name of the substance •The dosage form •The strength of the substance •The number of dosage units or volume in the container •The number of commercial containers received •The date of receipt •The name, address, and registration number of the supplier

Requirements for emergency prescriptions

•The quantity prescribed and dispensed is limited only to the amount necessary to treat the patient for the emergency period •The prescription must be immediately reduced to writing by the pharmacist and shall contain all required information, except the signature of the prescriber.•If the prescriber is not known to the pharmacist, the pharmacist must make a reasonable, good faith effort to determine that the oral authorization came from a registered individual practitioner •Within 7 days after authorizing an emergency prescription, the prescriber must deliver to the dispensing pharmacist a written prescription for the emergency quantity prescribed. •On receipt, the pharmacist shall attach this prescription to the emergency prescription previously reduced to writing. •If the prescriber fails to deliver the written prescription within the 7‐day period, the pharmacist must notify the nearest office of the DEA. Failure of the pharmacist to do so will void the authority to dispense without a written prescription.

Emergency partial fills

•When a pharmacist fills an oral order for a schedule II prescription in an emergency situation, it may be dispensed as a partial fill. •The quantity supplied must be noted on a written record of the emergency oral prescription or in the electronic prescription record. •The remainder of the prescription must be provided to the patient within 72 hours. After 72 hours, no further dispensing of the emergency prescription is allowed.

the retail pharmacy must write the words

"CENTRAL FILL" on the original paper prescription, then may transmit the prescription to the central fill pharmacy either via fax or electronically.

optometrist may not prescribe, dispense, or administer a controlled substance included in schedule I or II, with the following exceptions:

(a)Not more than 300 milligrams of hydrocodone per 100 milliliters or per 100 grams or not more than 15 milligrams per dosage unit, with a four‐fold or greater quantity of an isoquinoline alkaloid of opium. •(b)Not more than 300 milligrams of hydrocodone per 100 milliliters or per 100 grams or not more than 15 milligrams per dosage unit, with one or more active, nonnarcotic ingredients in recognized therapeutic amounts.

CARA partial fills

*Not included in WI law* but less strict federal law a pharmacist may provide partial fills of a schedule II medication up to 30 days from the date of the prescription.

4 ways of disposal or destruction of drug

1) By promptly destroying the substance on‐site in the presence of a DEA agent or authorized person 2) By promptly delivering the substance to a reverse distributor's registered location 3) By promptly delivering returns or recalled substances to the registered person from whom the substance was obtained, the registered manufacturer of the substance, or another registrant authorized by the manufacturer 4) Request assistance from the Special Agent in Charge of the Administration in the area where the registrant is located.

4 ways to partial fill a CII

1) CARA partial fills 2) Partial fill of an emergency prescription 3) Partial fill due to inability to supply 4) Partial fill for LTCF or terminal illness

No identification card is required if any of the following applies

1.The drug is administered or dispensed directly to the ultimate user by a practitioner. 2.The pharmacist or other person dispensing or delivering the drug has personal knowledge of the person to whom the drug is dispensed or delivered and that the person is the ultimate user or the ultimate user's authorized representative (still have to record the name if no ID is shown) 3.The drug is delivered to a health care facility to be administered in the health care facility.

DEA form for theft or significant loss

106

No person may sell a pseudoephedrine product to a person under 18 years of age, and no person under _____ years of age may purchase a pseudoephedrine product.

18 years

No person may sell at retail a drug containing dextromethorphan to a person who is under ______ years of age, unless the sale is pursuant to a prescription order.

18 years

DEA a report of theft or loss of controlled substances, the pharmacy, practitioner or other DEA registrant shall also send a copy to the board within

2 weeks of filing with the DEA.

Back up e‐prescription records daily and maintain for

2 years

Executed DEA Forms 222 must be maintained separately from all other records and retained by the purchaser and supplier for a period of _________

2 years

Records of pseudoephedrine sales shall be kept in electronic format and shall be maintained by the pharmacy for at least ____ years.

2 years

(per wi) Records required by the federal CSA, shall be maintained at the location where the drug is received, manufactured, distributed or dispensed, and be available for inspection by authorized persons for at least________

5 years

No schedule III or IV prescription may be filled or refilled more than ____ months after the date of issuance of the prescription, or more than ______ times, whichever comes first.

6 months, 5 times

prescription for a controlled substance listed in schedule II may not be dispensed more than

60 days after the date of issue on the prescription order

Within ___ days after authorizing an emergency prescription, the prescriber must deliver to the dispensing pharmacist a written prescription for the emergency quantity prescribed.

7 The prescription must have written on its face "Authorization for Emergency Dispensing" and the date of the oral order. The written prescription may be delivered to the pharmacist in person or by mail. If delivered by mail, it must be post‐marked within the 7‐day period.

No person other than a physician, dentist, veterinarian, or pharmacist may purchase more than ____ grams of pseudoephedrine contained in a pseudoephedrine product within a 30‐day period without the authorization

7.5 grams (daily requirement - follow federal 3.6 grams)

federal law does not require record keeping for

< 60 mg PSE

optometrist Rx shall include

A statement that he or she is allowed to use therapeutic pharmaceutical agents The indicated use of the controlled substance included in schedule III, IV, or V so prescribed or the indicated use of the controlled substance

SCLP self certification

All sellers must annually self‐certify on the DEA website by attesting that employees engaged in the sale of these products have been appropriately trained

Identification cards permitted

An operator's license issued An identification card issued (state issued ID) An identification card issued by a U.S. uniformed service A U.S. or foreign passport. A tribal identification card