2.4 Federal requirements for restricted drug programs and related medication processing

What is the CMEA?

A U.S. federal law regulating over-the-counter sales of products containing pseudoephedrine, ephedrine, and phenylpropanolamine to prevent methamphetamine production

What is the daily limit for purchasing pseudoephedrine?

3.6g (3,600 mg) pseudoephedrine base a day regardless of strength

What is the pharmacy limit for purchasing pseudoephedrine?

9g (9,000 grams) base product per 30 day sliding window

What is the mail-order limit for purchasing pseudoephedrine?

7.5g base product per 30 day sliding window

A patient wants to buy 24 tablets of 30mg pseudoephedrine. Is this allowed?

Yes

How many more tablets of 30mg pseudoephedrine can a patient still buy today if they have already bought 1800mg today.

60 tablets

What is the purpose of restricted drug programs?

Certain medications with serious safety risks can only be prescribed, dispensed, and used under strict, federally regulated conditions.

What is REMS and why is it required?

The FDA requires a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of a drug outweigh its risks.

What are the main goals of REMS programs?

Prevent or reduce serious adverse effects, educate prescribers, pharmacists, and patients, and track/control medication distribution.

What is the criteria for REMS implementation?

Severe Organ Damage, Birth Defects, SAE Rate >1%,

What are the REMS Requirements and Elements to Assure Safe Use (ETASU)?

Registration/certification of prescribers, pharmacies, and patients; documentation; limited dispensing; special labeling; ongoing monitoring; patient education/consent forms.

What are the prescription and dispensing limits for REMS?

Only 30 day supplies, no refills, written, dated and signed prescriptions only, no call-ins

What are the patient restrictions for REMS?

Female patients require two negative pregnancy tests within 7 days of picking up, patients must use two contraception forms

What are the provider and pharmacy requirements for REMS?

Prescriber and pharmacy must re-certify yearly

Do you document first or do you dispense first REMS and pseudoephidrene?

Document first always then dispense

Who can dispense Mifepristone?

Can only be dispensed in a healthcare setting, no pharmacy dispensing

Based on the Drug Supply Chain Security Act (DSCSA) what do you do if a REMS package is tampered with?

Quarantine, Notify Pharmacist, Complete Form 3911, Record TI/TS data

What is the Prescription Program for Lotronex (PPL)?

A REMS program for alosetron requiring prescriber enrollment, a patient-physician agreement, and PPL stickers on prescriptions.

What is the six step process for for REMS Workflow and Documentation?

Verify Drug List, Confirm Certification, Validate Enrollment, Capture Consent, Refuse Partial Fills (if program forbids it), Document Every Step

What is the main risk associated with alosetron (Lotronex)?

Severe gastrointestinal reactions, including bowel ischemia and severe constipation, which can lead to surgery or death.

What must prescribers do under the Lotronex REMS program?

Enroll in the program and sign a patient-physician agreement; only enrolled physicians may prescribe.

What is the Clozapine REMS Program designed to prevent?

Agranulocytosis (dangerous drop in white blood cell count).

What must pharmacies verify before dispensing clozapine?

Lab results showing acceptable WBC and ANC within 7 days; dispense only a specific day's supply; documentation required for each refill.

What is the iPLEDGE Program?

A REMS program for isotretinoin to prevent severe birth defects in female patients of childbearing potential.

What must female patients do under iPLEDGE?

Monthly negative pregnancy test, use two forms of birth control, and pick up only a 30-day supply within the specific time window.

Can isotretinoin be refilled under iPLEDGE?

No, refills are not allowed; a new prescription is required each month.

Is oral isotretinoin REMS or no?

Yes

Is topical isotretinoin REMS or no?

No

What is the Thalomid REMS Program for?

Prevention of severe birth defects (teratogenicity) in patients using thalidomide.

What are the requirements for Thalomid dispensing?

Prescriber, pharmacy, and patient registration; negative pregnancy test confirmation; verified contraceptive use; pharmacist must verify prescriber registration.

What is the TIRF REMS Access Program for?

To prevent overdose, abuse, and fatal respiratory depression in opioid-tolerant patients using transmucosal immediate-release fentanyl.

What must physicians do before prescribing TIRF products?

Complete education/training and sign a prescriber-patient agreement; monitor patients for signs of misuse or addiction at each visit.

What are FDA-required Medication Guides?

Patient information sheets required with certain high-risk prescriptions to help avoid adverse effects, explain safe use, and promote adherence.

Which drug classes commonly require Medication Guides?

NSAIDs, antidepressants, opioids, amphetamines, antiepileptics, and hypoglycemics.

What are technician responsibilities regarding Medication Guides?

Ensure correct guide is provided, maintain adequate stock, and confirm patient education materials are included.

What customer requirements apply when purchasing pseudoephedrine?

Must show valid photo ID, sign a logbook including name, address, date, time, quantity, and product sold.

Where must pseudoephedrine be stored in a pharmacy?

Behind the counter or locked.

Who may transfer controlled substance prescriptions?

Only a pharmacist may transfer or receive prescriptions (some states allow technician assistance).

Can Schedule II prescriptions be transferred?

No, Schedule II prescriptions cannot be transferred.

How many times can Schedule III-V prescriptions be transferred?

Once, unless using a shared real-time database, then up to authorized refills.

What key information must technicians obtain for a prescription transfer?

Patient name, DOB, other pharmacy name/number, prescription number, medication name.

What is the overall purpose of REMS programs?

Minimize drug-related risks through registration, patient education, lab monitoring, and restricted dispensing.

Why are Medication Guides required with high-risk drugs?

To promote safe use and ensure patient awareness of potential adverse effects.

Why are pseudoephedrine sales regulated federally?

To prevent illegal methamphetamine manufacturing.

What is the technician's role in REMS and restricted drug programs?

Maintain compliance, document properly, and ensure patient safety.