Transcript resticted drugs - cloudfront.net

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 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
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FDA can require a manufacturer to implement a
REMS
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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 decisionmaking 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.
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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.
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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,
Examples of Drugs with REMS
alosetron (Lotronex)
 clozapine (Clozaril, Fazaclo)
 isotretinoin (Accutane, Amnesteem,
Claravis, Sotret)
 thalidomide (Thalomid)
 dofetilide (Tikosyn)
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Alosetron
Treats a type of irritable bowel syndrome
(IBS)
 Serious adverse reactions of
gastrointestinal tract
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Restricted by Prescription Program for
Lotronex (PPL)
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some necessitate a blood transfusion or surgery
some even lead to death
requires physician enrollment & submission of
Patient-Physician Agreement Form
Prescriptions must be written by physician &
must include PPL sticker on face of prescription
Clozapine
Treats patients with schizophrenia
 Can cause serious drop in white blood
cells
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monitoring must be done regularly
Pharmacies must register to dispense
clozapine
 Specific day supply may be dispensed
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(1, 2, or 3 weeks depending on monitoring
frequency)
Pharmacy must receive documentation
of blood work
Isotretinoin
Treats severe acne & can cause serious
birth defects
 iPledge Program for isotretinion
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registration required by
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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
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Thalidomide
Treats multiple myeloma/erythema
nodosum leprosum
 Causes birth defects
 Thalidomide Education & Prescribing
Safety (S.T.E.P.S.) Program
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prescribers, patients, pharmacies must
register
 pharmacy must verify that the prescriber is
registered with S.T.E.P.S. before dispensing
medication
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Dofetilide
Treats irregular heart rhythms
 Can cause serious complications
 Patients must be hospitalized to initiate
therapy
 Tikosyn in Pharmacy System (T.I.P.S.)
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prescribers & pharmacists must register
 pharmacy must verify the prescriber’s
registration
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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.