1. RiskR EEvaSluTatIioCn TanEd DMi tiDgaRtioUn SGtrSategies--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. RESTICTED 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. 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,
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 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