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RESTRICTED DRUGS

RESTRICTED DRUGS. Risk Evaluation and Mitigation Strategies--REMS With each drug/biologic safety issue posing a serious risk, the question for FDA will be: to REM or not to REM? REMS---Food and Drug Administration Amendments Act of 2007

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RESTRICTED DRUGS

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  1. RESTRICTED DRUGS Risk Evaluation and Mitigation Strategies--REMS With each drug/biologic safety issue posing a serious risk, the question for FDA will be: to REM or not to REM? REMS---Food and Drug Administration Amendments Act of 2007 in 2006 the FDA listed 156 REMS for prescription medicines (128) and biologics (28) intended to ensure the benefits of the medication outweigh its risk why REMS??--Public outcry over revelations of unforeseen risks from trusted medicines(rofecoxib, valdecoxib, and salmeterol

  2. pregnancy categories • possible defects after much research…… • category A----no fetus risk shown • cat B---animal studies have shown no fetus risk, no adequate human studies • cat C---animal studies adverse fetus affect, no adequate human study. benefits over risk • cat D---evidence of human fetal risk but benefits over risk • cat X---animal or human fetal abnormalities, risk over benefit.

  3. RESTRICTED DRUGS • FDA can require a manufacturer to implement a REMS • Components of REMS • 1--Medication Guides--required for drugs and biologics(vaccine,macro,ect) when the FDA determines that: (a) certain information is necessary to prevent serious adverse effects, (b) patient decision-making should be informed by information about a known serious side effect of a product, or (c) patient adherence to directions for the use of a product is essential to its effectiveness.

  4. RESTRICTED DRUGS • 2--Communication Plans-- • Letters to healthcare providers; • Disseminating information about the REMS to encourage implementation; and • Disseminating information through professional societies about any serious risks of the drug and any protocol to assure safe use.

  5. RESTRICTED DRUGS • 3--Elements to Assure Safe Use(ETASU) • may include one or more of the following • Special training, certifications, or demonstration of experience for prescribers of the drug/biologic • Certification of pharmacies, practitioners, or healthcare settings that dispense the drug/biologic • Limitations as to the healthcare settings where the drug/biologic may be dispensed • Evidence of special safe-use conditions--patients receive the drug/biologic only after specified authorization,proof of counseling, periodic blood tests • monitor the number of prescriptions dispensed, adverse events,

  6. Examples of Drugs with REMS alosetron (Lotronex) clozapine (Clozaril, Fazaclo) isotretinoin (Accutane, Amnesteem, Claravis, Sotret) thalidomide (Thalomid) dofetilide (Tikosyn)

  7. Alosetron=Lotronex • Treats a type of irritable bowel syndrome (IBS) • Serious adverse reactions of gastrointestinal tract • some necessitate a blood transfusion or surgery • some even lead to death • Restricted by Prescription Program for Lotronex (PPL) • requires physician enrollment & submission of Patient-Physician Agreement Form • Prescriptions must be written by physician & must include PPL sticker on face of prescription

  8. Clozapine=Clozaril • Treats patients with schizophrenia • Can cause serious drop in white blood cells • monitoring must be done regularly • Pharmacies must register to dispense clozapine • Specific day supply may be dispensed • (1, 2, or 3 weeks depending on monitoring frequency) • Pharmacy must receive documentation of blood work

  9. Isotretinoin=accutane • Treats severe acne & can cause serious birth defects • iPledge Program • registration required by • doctors • patients • Pharmacies • must meet specific requirements / answer questions with iPledge Program each time drug dispensed. You must have two negative pregnancy tests before starting this medication. You must have a monthly pregnancy test during treatment with isotretinoin. If the test is positive, you must stop taking this medication and consult your doctor right away. • quantity dispensed is limited • prescription must be picked up within limited time

  10. Thalidomide=Thalomid • Treats multiple myeloma/erythema nodosum leprosum • Causes birth defects • Thalidomide Education & Prescribing Safety (S.T.E.P.S.) Program • prescribers, patients, pharmacies must register • pharmacy must verify that the prescriber is registered with S.T.E.P.S. before dispensing medication

  11. Dofetilide=Tikosyn • Treats irregular heart rhythms • Can cause serious complications • Patients must be hospitalized to initiate therapy • Tikosyn in Pharmacy System (T.I.P.S.) • prescribers & pharmacists must register • pharmacy must verify the prescriber’s registration

  12. special rx programs methadone maintenance tx----MMT methadone/dolpohine/methadose is used for opioid addiction. do don’t give over 1 day supply. must ingest at dr office or drug tx center. also for chronic pain or cancer pain. suboxone and subutex(opioid addiction) sch3 sublingual must have pt do paperwork. you may get rx for this but requires special training for dr to rx. will have X with DEA number.

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