Chapter 8.2: Restricted programs: REMS and Pseudoephedrine (CMEA)

what does FDA do?

• determines if drug is safe and effective

• if it’s dangerous → it’s denied/removed from market

What safety program does FDA use for medicine that has more severe side effects but provide life-saving benefits?

• Risk Evaluation and Mitigation Strategies (REMS)

  • mandatory safety program that acts as a “firewall” between drug and the patient

who dispenses REM medicine and what do they have to do?

• manufacturer, prescribers, pharmacy, and patients must often perform specific actions before the medicine can be dispensed

  • enroll in federal registry

  • complete safety training

  • submit lab results

what is isotretinoin? what is the primary risk?

• generics: Claravis, Absorica, used to be known as Accutane

• for severe, scarring acne

• primary risk: teratogenicity (catastrophic birth defects if taken during pregnancy)

  • structural deformity of heart and brain

what is the REMS program for isotretinoin? how do they use it?

• iPledge

  • female patients have to commit to 2 types of birth control and have a negative pregnancy test every month at a certified lab

  • pharmacy must log into iPledge and confirm a patient is “cleared” before filling

    • Rx must be filled within 7 days from the pregnant test date; if pt misses this window, Rx is void and process restarts

what is clozapine and what is the primary risk?

• antipsychotic medicine for schizophrenia that doesn’t respond to other treatments

• fatal side effect: Severe Neutropenia (very low count of neutrophils) → suppresses immune systems, leaving the body defenseless against infection

what is the REMS program/safety protocol for clozapine?

• “No Blood, No Drug”

  • before dispensing, pharmacy must obtain patients absolute neutrophil count (ANC)

  • verify lab result w/ Clozapine REMS program database

  • if ANC is lower or test is not current (within 7 days), system will reject dispensing

what is thalidone and what is the primary risk?

• historically known for causing Phocomelia (severe limb deformation) in babies in 1960s

• used to treat multiple myeloma (blood cancer) and leprosy, but risk to fetus is still present

what is the REMS program/safety protocol for thalidomide?

• REMS requires mandatory registration, extensive patient education, and strict birth control measures

  • applies to men and women because it can be transmitted through sperm

  • men taking thalidomide must agree to barrier contraception to protect female partners

what are TIRF products and what is the primary risk?

• Transmucosal Immediate-Release Fentanyl (TIRF)

• potent opioid form. designed to enter the bloodstream rapidly through tissues of mouth/nose

  • Fentanyl “lollipop) (Actiq)

  • Sublingual tablets like Fentora

• Side effects: respiratory depression

  • the drug is so potent that standard dose could stop the breathing of a pt who is not physically accustomed to opioids

what is the REMS program/safety protocol for TIRF products?

• REMS program require that these drugs can only be prescribed to “opioid tolerant” patients

  • opioid tolerant: someone who has already been taking high doses of chronic opioid (like morphine or oxycodone) for at least a week

  • dispensing TIRF product to an “opioid-naive” patient is a critical error

what is Tysabri and what is the primary risk?

• natalizumab (tysabri) is an infusion drug used for Multiple Sclerosis and Crohn’s Disease

  • carries risk of rare but often fatal brain infection called Progressive Multifocal Leukoencephalopathy (PML)

what is the REMS program/safety protocol for Tysabri?

• drug is distributed only through TOUCH prescribing program

• patients must be monitored for signs of brain infection (changes in thinking/vision) before any infusion

what is Lotronex and what is the primary risk?

• alosetron (lotronex) is used for women with severe Irritable Bowel Syndrome (IBS) involving diarrhea

  • can cause ischemic colitis (reduced blood flow to intestines)

what is the REMS program/safety protocol for Lotronex?

• prescribers must be certified in the program and pharmacy must look for “PPL” sticker/verification on Rx hardcopy indicating the patient has been counseled on risks

what is Qsymia and what are the primary risks?

• weight-loss combination drug containing Phentermine and Topiramate

• Topiramate is associated with high risk of cleft lip and cleft palate in fetuses

what is the REMS program/safety protocol for Qsymia?

• REMS program focuses on avoiding pregnancy

• does not require monthly portal login for every fill, but pharmacy must be specifically certified to dispense it and provide specific patient education materials

What is the CMEA?

• Combat Methamphetamine Epidemic Act of 2005

  • targets specific chemicals used to make meth, most notably Pseudoephedrine (PSE)

Why was CMEA established?

• meth cooks used many common OTC decongestants to extract active ingredients needed for meth production

What is the new category created for drugs like PSE/Sudafed?

• Made by the CMEA

• Called “Scheduled Listed Chemical Products” (SLCP)

• treated with increased security protocols but are not like control substances (C-II to C-V); restricted OTC product

  • only placed behind the counter, no product with PSE are on open shelves

what is the age restriction for buying restricted OTC products?

• at least 18 years old or older

how are restricted OTC product sales recorded?

• most pharmacies use NPLEX (National Precursor Log Exchange)

• before completing sale, techs scan ID to check if customer has bought Sudafed at other pharmacies

  • sale is blocked if limit has exceeded

what is the daily limit that a customer can buy for PSE?

• Less than or equal to 3.6 grams of PSE per day

what is the retail monthly limit that a customer can buy for PSE?

• 9 grams for a 30 days period

what is the mail order monthly limit that a customer can buy for PSE?

• sale is capped at 7.5 grams for a 30 day period

what is a communication plan pharmacies must do when patients are picking up medications with potential health risks?

• communication plan: requires dispensing MedGuide with every fill

  • required for drug classes like NSAIDs, antidepressants, and opioids