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. RESTRICTED DRUGS
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. 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.
4. 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. 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
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
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