1. RESTICTED 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 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. RESTICTED DRUGS Components of REMS
FDA can require a manufacturer to implement a REMS
Components of REMS
1--Medication Guides--required for drugs and biologics 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.

3. RESTICTED 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.

4. RESTICTED 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,

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

6. Alosetron 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

7. Clozapine 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

8. Isotretinoin Treats severe acne & can cause serious birth defects
iPledge Program for isotretinion
registration required by
doctors
patients
Pharmacies
must meet specific requirements / answer questions with iPledge Program each time drug dispensed
quantity dispensed is limited
prescription must be picked up within limited time

9. Thalidomide 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

10. Dofetilide 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

11. special rx programs methadone maintenance tx----MMT
methadone/dolpohine/methadose is used for opiod
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
sch2 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.