Law: Controlled Substances Part 3

Substance Use-disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act of 2018: Granted NPs and PAs permanent prescribing authority of buprenorphine for opioid addiction Expanded DATA-waived practitioners to include qualified clinical nurse specialists, certified nurse anesthesists, and certified nurse midwives Expanded eligibility to treat up to _____ patients at a time in the first year as a DATA-waived practitioner Allows eligible practitioners to apply to increase the treatment limit to _____ patients after treating 1000 patients for one year

100 275

Only the pharmacist can dipense a non-Rx CS to a patient, who must be at least _____ yo. If the pharmacist does not know the patient, the patient must provide proper identification. The pharmacist must record the following information in a bound record book: Patient name and address Drug name and quantity purchased Date of purchase Pharmacists's name and initials

18

The prescription transfer information may be documented electronically. Federal law requires records to be kept for _____

2 years

When a prescription is received electronically, federal law requires that the prescription and all required annotations (i.e., prescription corrections) must be stored electronically for at least ______

2 years

These drugs may contain codeine, an opiate. For this reason, there are federal limits on the amount of drug that can be dispensed every two days: _____ ml (____ ounces) or _____ dosage units of any CS containing opium ____ ml (____ ounces) or ____ dosage units of any other CS

240 ml (8 ounces) or 48 dosage units 120 ml (4 ounces) or 24 dosage units

2.) Under the 2016 Comprehensive Addiction and Recovery Act (CARA), pharmacists can partially fill schedule II drugs at the request of the patient or physician. Not all states have added this amendment to their legal statutes Additional partial fills can only be dispensed up to ______ from the date of the prescription was issued There is no limit on the number of partial fills a patient can receive pursuant to one prescription, as long as the total quantity dispensed does not exceed the total quantity prescribed

30 days

DATA 2000 limits number of patients the physician can treat for opioid addiction at a time to _____ patients in the first year and with potential eligibility to treat _____ patients after the first year

30; 100

Clinics must register with the DEA using DEA form _____ in order to operate as an OTP

363

Methadone is an effective schedule II drug used to treat opioid dependence, but ir must be dispensed and administered through a registered opioid treatment program (OTP). The methadone ____ mg soluble tablet is only FDA-approved for treating opioid addiction; the lower doses are indicated for the treatment of pain and opioid dependence

40 mg

In PA, what is the max refills allowed for schedule III-V drugs

5

Schedule III-V drugs may be refilled up to a max of _____ within _____ of the date written. A new prescription is needed after ____ refills are reached or _____, whichever comes first. The original fill is not counted as a refill, so a prescription of 5 refills count as 6 fills.

5 times within 6 months

Example: BM6125341 Step 1 Step 2 Step 3 Step 4 Is the DEA number valid?

6 + 2 + 3 = 11 1 + 5 + 4 = 10 10 x 2 = 20 20 + 11 = 31 Last digit 1 matches, DEA is valid

According to federal law, prescriptions for non-scheduled and schedule V drugs do not expire, whereas prescriptions for schedule III-IV drugs are only valid for _____ from the issue date

6 months

In PA, what is the expiration date for a schedule III-V prescription?

6 months

In PA, what is the time limit that a schedule II prescription must be filled from the date of issue?

6 months

In PA, how long are refills valid for schedule III-V drugs

6 months from the issue date

3.) Schedule II drugs can be partially filled for patients residing in an LTCF or patients diagnosed with a terminal illness. The pharmacist must document "terminally ill" or LTCF patient on the prescription Partial fills can be dispensed up to _____ days from the date the prescription was issued

60 days

Criteria for dispensing pursuant to an oral schedule II prescription: Dispense the minimum necessary amount Prescriber must provide the original prescription within ______ of oral administration Face of the original must include the statement :Authorization for Emergency Dispensing" and the date of the oral prescription If the original prescription is not received within ____, the pharmacist must report the breach to the local DEA office

7 days

There are 3 circumstances in which a schedule II drug may be partially filled 1.) If the pharmacy cannot supply the full quantity This partial fill can be provided pursuant to a written or an emergency oral prescription The quantity supplied must be documented on the face of the hard copy or in the electronic prescription record The remaining portion must be filled within _____ of the first partial filling. After _____, a new prescription is required If the remainingportion is not or cannot be filled within 72 hours of the first partial filling, the pharmacist must notify the prescriber

72 hours

A faxed prescription can serve as the original copy for a schedule II drug in three scenarios:

A drug compounded for administration to a patient by parenteral, IV, IM, SC or intraspinal route A prescription for a resident of a LTCF A prescription for a patient enrolled in a hospice program

In PA, is naloxone distribution by a pharmacist permissable in all situations, or is it pursuant of a standing order, a protocol, or authorization form a prescriber?

It is permissable under a standing order or dispensed pursuant to a valid prescription

Which healthcare professionals are authorized to access the PDMP in PA?

Licensed prescribers and pharmacists, or their approved delegates, and the medical examiner or county coroner

In PA, which controlled substance schedules (if any) can each type of mid-level practitioner prescribe?

NPs and PAs with registration with the DEA may prescirbe controlled substances per a written collaborative agreement with a physician NPs: schedule II drugs (up to a 30-day supply) and schedules III-V (up to a 90-day supply) PAs: schedule II drugs (up to a 30-day supply with the approval of a supervising physician) and schedules III-V

In PA, can a pharmacist provide an emergency fill of schedule III-V drugs without a prescriber's authorization?

No

In PA, is patient identification required to dispense CS?

No

In PA, is there a limit to the number of medications that can be written on one prescription form?

No

In PA, is there a max quantity or days supply that a patient can receive of a schedule II drug?

No

In PA, what timeframe must a pharmacy submit records of dispensed CS to the state's PDMP?

No later than the close of the next business day

In PA, are partial fills for schedule II prescriptions permitted at the request of the physician or patient?

No, CARA has not be adopted into to state law as of yet

In PA, are there any additional requirements for an emergency oral schedule II prescription?

No, PA follows federal law

In PA, are pharmacists permitted to sell select schedule V cough syrups without a prescription?

No, except if dispensing within an institution

In PA, what security elements must be present on tamper-resistant security forms?

One or more industry recognized features to prevent the following: 1.) Unauthorized copying 2.) erasure or modification 3.) use of counterfeit forms

For all controlled substances, there are 3 items that cannot be changed:

Patient name Prescribed drug (except for generic substitution) Prescriber signature

In PA, what changes can be made, at the pharmacist's discretion, to schedule III-V drugs?

Same as schedule II prescriptions

In PA, can controlled and non-controlled drugs be written on the same prescription?

Schedule II-V drugs are required to be electronically prescribed unless an exception is met. If an exception is met, restrictions on prescribing non-controlled and controlled drugs on the same prescription form are not mentioned in state law

For PA, list the schedules of drugs collected in the states PDMP

Schedules II-V

In PA, other than prescriptions for Medicaid patients, do any prescriptions require tamper-resistant security forms?

Tamper-resistant forms are only specifically required for Medicaid patients

In PA, what changes can be made, at the pharmacist's discretion, to shcedule II prescriptions?

The three items above cannot be changes Other items, such as drug strength, quantity and directions for use, may be changes after consultation with prescriber

In PA, is there a max quantity or day's supply that a patient can receive of schedule III-V drugs?

There are no general limitations There is a 7-day supply limit on prescrining opioids for acute pain in emergency departments and urgent care facilities

If a practitioner is authorized to prescribe narcotics for opioid addiction, the practitioner will receive a DATA 2000 waiver unique identification number (UIN). The number is the same as the practitioners DEA number, except that the letter ____ replaces the first letter

X

Determining validity of DEA number: Step one: Step two: Step three: Step four:

add 1st, 3rd and 5th digits together add the 2nd, 4th and 6th digits together Multiply result of step two by 2 Add the results of step one and step three. The last digit of this sum should match the last digit of the prescriber's DEA number. This last digit is called the "check digit"

Prescribers do not need a DATA waiver to prescribe _______ products for treating pain, but they must specify the indication on the prescription

buprenorphine

First letter of DEA number for each registrant type: A/B/F/G: M: P/R: X:

hospital, clinic, teacjing institution, pharmacy mid-level practitioner manufacturer, distributor, researcher, analytical lab, importer, exporter, reverse distributor, narcotic treatment program DATA-waived practitioner

DEA numbers: Starts with 2 letters: First letter: identifies the type of practitioner or institution Second letter: first letter of the prescriber's _______ Letters followed by ___ numbers Last number is a "check digit"

last name 7

Schedule III-V drugs are allowed ____ transfer that must be communicated directly between two licensed pharmacists (some states may permit interns or certified pharmacy technicians to transfer) The only exception is if the pharmacies share a real-time, online database of the prescription recordkeeping system. Pharmacies with shared systems can transfer up to the max number of refills on the prescription

one

A practitioner without a DATA waiver may administer (but not prescribe) a ___ day supply of medication at a time to a patient while arranging the proper referral to an OTP. This can be done for up to ____ hours and cannot be extended.

one 72 day

Methadone take-home supply dispensing restrictions: First 90 days (days 1-90): can receive ____ take-home dose per week Second 90 days (91-180): can receive up to ____ take-home doses per week Third 90 days (181-270): can receive up to ____ take-home doses per week Treatment beyond 270 days and less than one year (270-364): can receive a max of ______ of take-home medication After one year: can receive a maximum _______ Sfter 2 years: can receive a max ______, but must have monthly visits

one two three 6-day supply two-week supply one-month supply