Law Class PowerPoint Flashcards
Federal Law
Drug Disposal: What is the Act and what does it entails ?
- Secure and Responsible Drug Disposal Act
- The goal of this Act is to allow for the collection and disposal of Controlled
Substances in a secure, convenient, and responsible manner - Also reduces diversion and the introduction of some potentially harmful substances into the environment
- need to search online/ DEA website to find site
Consolidated Appropriations Act of 2023
- Eliminated the “DATA-Waiver Program”
- Elimination of the X-waiver program including elimination of
– X-waiver DEA Registration
– Patient caps
The Act introduced new training requirements for all prescribers to
go into effect June 27, 2023
The DEA and SAMSHA will provide guidance and information
The slide covers a section of the Consolidated Appropriations Act of 2023, which includes updates relevant to healthcare providers, especially those handling controlled substances.
Here’s a breakdown:
1. Elimination of the “DATA-Waiver Program”: • Previously, healthcare providers needed a special “X-waiver” from the Drug Enforcement Administration (DEA) to prescribe medications like buprenorphine for treating opioid use disorder. This waiver was associated with specific requirements and patient limits. • The act has removed the need for this separate X-waiver DEA Registration, which means any DEA-registered practitioner can now prescribe these medications without needing an additional waiver. 2. Patient Caps Removed: • Under the X-waiver program, providers were limited in the number of patients they could treat with medications like buprenorphine. Removing the X-waiver also eliminates these patient caps, allowing providers to treat more patients in need. 3. New Training Requirement: • All prescribers registered with the DEA are now required to complete a one-time, 8-hour training focused on treating and managing patients with substance use disorders. • This training became mandatory starting on June 27, 2023. The DEA and SAMHSA (Substance Abuse and Mental Health Services Administration) are tasked with providing guidance on fulfilling this requirement.
In summary, this legislation simplifies access to treatment for opioid use disorder by removing previous restrictions (X-waiver) and setting a new training standard for DEA-registered providers.
.
* One-time, 8-hour training requirement for all Drug Enforcement
Administration (DEA)-registered practitioners
* On the treatment and management of patients with opioid or other
substance use disorders.
* All DEA-registered practitioners, with the exception of practitioners
that are solely veterinarians.
* Initial registration application or renewing their registration
DEA Updates the electronic 106 Form for Reporting Theft or Loss of Controlled
Substances…what’s the update?
- Requires registrants to include the NDC which will help to accurately track
controlled substances reported as stolen or lost - Required to report a “Significant Loss”— “. . . the repeated loss of small quantities of
controlled substances over a period of time may indicate a significant aggregate problem that must be reported to DEA, even though the individual quantity of each occurrence is not significant.” - NMBOP Definition for significant loss: includes suspected diversions, in-transit losses or any other unexplained loss and must be reported to the Board of Pharmacy within five (5) days of becoming aware of that loss (but notiffy DEA in 1 day)
Q: What are the rules regarding prescription transmission for controlled substances?
A: An authorized agent can prepare a prescription for a DEA-registered practitioner’s signature. For Schedule III-V drugs, they may transmit the practitioner-signed prescription via facsimile or orally to a pharmacy. For Schedule II prescriptions, an authorized agent can fax the signed prescription for patients in hospice or long-term care facilities (LTCF). Additionally, the SUPPORT for Patients and Communities Act mandates electronic prescribing of controlled substances (EPCS) for all controlled substances under Medicare Part D by January 1, 2022.
CARA 2016
The Comprehensive Addiction and Recovery
Act (CARA)
- First major federal addiction legislation in 40 years and the most comprehensive effort to address the opioid epidemic.
- Partial Fills of Schedule II Controlled Substances: Amends the Controlled Substances Act by allowing schedule II substances to be partially filled if certain conditions and restrictions are met.
Q: What are the rules for transferring original prescription information for Schedule III, IV, or V controlled substances?
A: Original prescription information for these controlled substances can be transferred between pharmacies on a one-time basis for refill dispensing. However, if pharmacies share a real-time, online database, they may transfer up to the maximum refills allowed by law and the prescriber’s authorization. After the original prescription is filled, the transfer must be communicated directly between two licensed pharmacists.
Q: What are the rules for transferring electronic prescriptions for Schedules II-V controlled substances between pharmacies for initial filling?
A: Electronic prescriptions can be transferred at the request of a patient on a one-time basis. The transfer must be communicated directly between two licensed pharmacists, and the prescription must remain in its electronic form throughout the process.
Q: What are the DEA regulations regarding employment screening for access to controlled substances?
A: According to DEA regulations, a registrant shall not employ anyone as an agent or employee with access to controlled substances if they have been convicted of a felony offense related to controlled substances, or if they have had a DEA registration application denied, a registration revoked, or surrendered for cause.
Q: What is the DEA Controlled Substance Ordering System (CSOS)?
A: CSOS allows for secure electronic transmission of controlled substance orders, eliminating the need for the supporting paper DEA Order Form 222.
Q: What is the Drug Quality and Security Act (H.R. 3204)?
A: The Act differentiates between compounders engaged in traditional pharmacy practice (503A, a licensed pharmacy) and those producing large volumes of sterile compounded drugs without individual prescriptions (503B, an FDA-registered outsourcing facility).
Q: What are the licensure requirements for outsourcing facilities in New Mexico?
A: Any outsourcing facility that distributes compounded sterile drugs into New Mexico must be registered under the Federal Food, Drug, and Cosmetic Act and licensed by the New Mexico Board of Pharmacy (NMBOP) as an outsourcing facility. Providers may purchase non-patient-specific compounded sterile products for administration from a licensed outsourcing facility.
Q: What are the qualifications for compounding drugs under FDA Section 503A?
A: To qualify for 503A exemptions, a compounder cannot regularly or excessively compound drug products that are essentially copies of commercially available drugs. A compounded drug is not considered a copy if changes are made for an individual patient that produce a significant difference from the commercially available product, as determined by the prescriber.
FDA Guidance for Compounding “Essentially a copy” of a commercially available drug
product if:
- Same Active Pharmaceutical Ingredients (API) as a commercially available drug product
- API have same, similar (within 10%), or an easily substitutable dosage strength
- Commercially available drug product can be used by the same route of administration
- Combination of more than one commercially available drug is still a copy, even if the combination is not commercially available.
Q: What defines a generic drug according to the U.S. Department of Health and Human Services?
A: A generic drug is identical to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use, demonstrating bioequivalence. Drugs evaluated as “therapeutically equivalent” can be expected to have the same effect when substituted for the brand-name product. The FDA considers drug products substitutable if they meet therapeutic equivalence criteria, even if they differ in characteristics like shape, flavor, or preservatives.
Q: What is the FDA’s role in drug recalls?
A: A drug recall can be initiated by a company or requested by the FDA. The FDA’s role is to oversee the company’s recall strategy, assess the adequacy of their actions, and classify the recall.
New Mexico Law
&
Board Activity
Q: What constitutes dishonorable conduct by a facility according to the conduct update?
A: Dishonorable conduct may include:
- (18) Failing to provide a work environment that enables pharmacists and interns to perform their duties requiring professional judgment, including sufficient staffing to prevent fatigue and distractions.
- (19) Introducing external factors like productivity quotas that interfere with the ability of pharmacists, interns, or technicians to provide professional services.
- (20) Retaliating against pharmacy employees for reporting violations of board requirements, including unreasonable workloads that prevent them from fulfilling their duties as outlined in board rules and statutes.
A licensed pharmacy may compound non-sterile, non-controlled substance preparations for veterinarian office use in reasonable quantities. These preparations may be dispensed by a veterinarian under the following conditions:
- A valid veterinarian-client-patient relationship exists.
- The dispensed amount is for a single course of treatment, not exceeding a 5-day supply.
- The patient has an emergency condition requiring the compounded drug.
- Timely access to a compounding pharmacy is unavailable.
- The medication is not a controlled substance.
Q: What are the regulations for prescription adaptation by a pharmacist under NMAC?
A: A pharmacist may, using professional judgment, adapt a new non-controlled substance prescription by:
- Changing the quantity, dosage, dosage form, or directions for use to meet the intent of the prescriber.
- Completing any missing information on the prescription.
The pharmacist must notify the prescriber within 24 hours, maintain documentation, and provide counseling that includes relevant information about the prescription adaptation.
Q: What are the key amendments to controlled substances regulations under NMAC?
A:
- 16.19.20 NMAC, Section 42: Effective April 1, 2021, this amendment requires electronic prescribing of controlled substance (EPCS) prescriptions, with specified exceptions.
- 16.19.20 NMAC, Section 69: This amendment deschedules drug products approved by the FDA that contain cannabidiol derived from cannabis and no more than 0.1 percent tetrahydrocannabinols.
NMAC 16.19.20.42 B (1)
All CS prescriptions electronically transmitted except:
(a) for patients residing in an intermediate care, skilled nursing or correctional facility;
(b) for patients enrolled in hospice;
(c) for an animal by a licensed veterinarian;
(d) a prescription dispensed by a federal facility not subject
to state regulation (e.g. department of veteran affairs, Indian health services, military bases);
(e) a prescription requiring information that makes
electronic transmission impractical, such as complicated or lengthy directions for use or attachments; or new medications not yet in electronic system;
(f) for compounded prescriptions;
(g) for prescriptions issued during a temporary technical or electronic failure at the practitioner’s or pharmacy’s location;
(h) for prescriptions issued in an emergency pursuant to federal law and rules of the board;
(i) for prescriptions issued in response to a public health emergency where a non-patient specific prescription would be permitted;
(j) under extenuating circumstance, not inconsistent with federal law and where the practitioner communicates directly with the pharmacist. The pharmacist, using professional judgment, may accept the non-EPCS and is responsible for ensuring documentation of the circumstance in the prescription record; and that the prescription is otherwise in compliance with state and federal law and rules.
Q: What are the regulations for compounded sterile preparations under NMAC?
A: Compounded sterile preparations must be compounded according to all applicable USP chapters numbered less than <1000>, including:
- USP 797: Focuses on the sterile compounding of pharmaceuticals.
- USP 800: Effective December 1, 2019, mandates that hazardous compounding must occur in a negative pressure room, and hazardous and non-hazardous compounding cannot take place in the same room.
NMAC Repackaging and Distribution by a Pharmacy for Administration
* Pharmacy licensed by the board may repackage under the following conditions:
– By a managing pharmacy for use in an automated drug distribution system of a licensed health care facility (for administration)
– To a clinic under the same ownership as the pharmacy, for administration to clinic patients (not dispensing)
– Must be repackaged into a sealed unit-dosed container with appropriate BUD, and properly labeled
Q: What are the regulations for automated drug distribution systems under NMAC?
A:
- A managing pharmacy may use an automated drug distribution system to supply medications for patients in a licensed health care facility or inpatient hospice facility.
- The system can be located in a facility different from the managing pharmacy.
- It is considered an extension of the managing pharmacy.
- If the system contains controlled substances for routine dosing, the managing pharmacy must submit and maintain a separate registration with the DEA.
Q: What are the regulations for emergency drug supply (E-Kit) in a licensed custodial care facility under NMAC?
A:
- The “E-Kit” emergency drug supply may not be used for routine doses.
- It can only be accessed by licensed personnel on duty.
- Controlled substances may be included only if there is a nurse on-site 24/7.
- The E-Kit can function as an automated drug distribution system.
- Separate registration with the DEA is not required, as the E-Kit is not used for routine dosing.
Q: What does NMSA 27-2-12.21 state about prescription synchronization?
A: Prescription drug or device benefits must allow an insured to fill or refill a prescription for less than a thirty-day supply, applying a prorated daily copayment or coinsurance if:
- The prescribing practitioner or pharmacist determines it is in the best interest of the insured.
- The insured requests or agrees to receive less than a thirty-day supply.
- The reduced fill or refill is intended to synchronize the insured’s prescription drug fills.
- The insurer shall allow a pharmacy to override any denial indicating that a
prescription is being refilled too soon for the purposes of medication synchronization; and prorate a dispensing fee to a pharmacy that fills a prescription with less than a thirty-day supply
NMSA Drug, Device & Cosmetic Act
- Pharmacists may combine refills up to a 90 day supply.
- No controlled substances.
- Practitioner can specify no combining of refills on prescription.
Conscientious Objection
- A pharmacist who declines to fill a prescription for reasons of conscience shall personally:
- (1) promptly so inform the patient, if possible, and any person then authorized to make health-care decisions for the patient;
- (2) provide continuing care to the patient until a transfer can be effected; and
- (3) unless the patient or person then authorized to make health- care decisions for the patient refuses assistance, immediately make all reasonable efforts to assist in the transfer of the patient to another health-care practitioner or health-care institution that is willing to comply with the individual instruction or decision.
Q: What are the regulations for partial filling of Schedule II prescriptions under NMAC?
A:
- A Schedule II prescription may be partially filled if the total quantity dispensed does not exceed the prescribed amount.
- Remaining portions must be filled no later than 30 days after the prescription date.
- If a Schedule II prescription is initially filled more than 30 days from the date written, it may be partially filled if:
1. The pharmacist is unable to dispense the total prescribed quantity.
2. The partial fill amount is recorded on the written or electronic prescription record.
3. The remaining portion is filled within 72 hours of the partial filling.
4. The pharmacist notifies the prescribing physician if the remaining portion cannot be filled within 72 hours; no further quantity may be supplied beyond 72 hours without a new prescription.
NOTE: Partial filling of a CII RX for Hospice or LTCF patients is allowed for a period of 60 days from the date of issuance.
Q: What are the regulations for partial filling of Schedule III-V prescriptions under NMAC?
A: Partial filling is allowed for Schedule III-V prescriptions provided that:
- The total quantity of all partial fills does not exceed the total quantity prescribed.
- No dispensing occurs after 6 months from the date the prescription was written.
PAIN RELIEF ACT (2019 amendment)
.
Q: What are the key provisions of the Pain Relief Act (2019 amendment) regarding opioid overdose?
A:
- Health care providers who prescribe, distribute, or dispense opioids must advise patients about overdose risks and co-prescribe an opioid antagonist under certain circumstances.
- This requirement applies when:
- An opioid analgesic is prescribed for the first time to a patient.
- An opioid is prescribed for the first time each calendar year.
- An opioid antagonist must be co-prescribed if the opioid is for at least a five-day supply.
- Providers must provide written information about the temporary effects of the opioid antagonist and administration techniques, including a warning to call 911 immediately after administering the antagonist.
- Note: Pharmacists dispensing opioids are not considered health care providers under this context.
