market research to support their utility at the healthcare practice setting. Tools can include training videos, protocols, laboratory monitoring schedules, sample informed consent agreements between patient and healthcare practitioner, and other data collection tools. Generally, any tool that is likely to improve the risk/benefit ratio should be considered, as differing healthcare practice settings require different tools and education techniques. Hospitals and health systems often require different tools than those used by physician practices or pharmacies.
TAblE 2
botox®/botox® Cosmetic (onabotulinumtoxinA) injection Cimzia® (certolizumab pegol) lyophilized powder for solution for subcutaneous injection Dysport™ (abobotulinumtoxinA) injection Effient™ (prasugrel) tablets Embeda™ (morphine sulfate and naltrexone hydrochloride) extendedrelease capsules Entereg® (alvimopan) capsules
7/31/2009
REMS components (All REMS include timetable for assessment.)
Medication guide, communication plan
modified
12/31/2008
and 5/13/2009
Medication guide, communication plan Medication guide, communication plan Medication guide, communication plan Medication guide, communication plan Modified 2/5/2009
Elements to assure safe use, or ETASU, are designed to control access to a drug with known serious risks that otherwise would be unavailable. ETASU seek to limit the saleable market to only those healthcare practitioners and facilities most familiar with the treatment of patients who can be appropriately treated with the REMS drug. In each ETASU case, the drug is deemed to be effective, but the risk profile is viewed as likely to cause a serious adverse event if elements of the REMS are not implemented. In order to maintain a sterile environment for safe use of the drug, ETASU often are combined with a performance linked access system, or PLAS.
As discussed under the medication guide section, the FDA intends through the use of ETASU and PLAS to drive “ performances/ac-tivities” between healthcare practitioner and patient that can serve to reduce the risk profile for the drug in each patient. ETASU have become a major consideration of drugs entering the specialty markets, as these REMS drugs often require the patient, healthcare practitioner, pharmacy and distributor to link their performances to maintain the safe drug use environment.
Classic characteristics of ETASU with PLAS include healthcare practitioner attestations, whereby the healthcare practitioner attests that he or she will complete the required elements of the REMS that can enhance the risk/benefit ratio for a drug’s use. Confounding factors include how to ship and dispense such products to healthcare practitioners and the facilities of their practice sites. Since many
Forteo® (teriparatide [rDNA origin]) injection letairis® (ambrisentan) tablets Multaq® (dronedarone) tablets Myobloc® (rimabotulinumtoxinb) injection Nplate™ (romiplostim) for subcutaneous injection
7/22/2009
5/29/2009; modified 7/1/2009 and 8/5/2009
7/1/2009
7/31/2009
8/22/2008; modified 8/14/2009
Communication plan, elements to assure safe
use, implementation system
Medication guide, communication plan
Medication guide, elements to assure safe use,
implementation system
Medication guide, communication plan
Medication guide, communication plan
Medication guide, communication plan, elements
to assure safe use, implementation system
Onsolis™ (fentanyl buccal soluble film)
7/16/2009
OsmoPrep® (sodium phosphate, dibasic anhydrous and sodium phosphate, monobasic, monohydrate) tablets Promacta® (eltrombopag) tablets
10/13/2009
Medication guide, communication plan, elements to assure safe use, implementation system Medication guide, communication plan
11/20/2008
Sabril® (vigabatrin) tablets and oral solution 8/21/2009
Samsca™ (tolvaptan) tablets Simponi™ (golimumab) injection Stelara™ (ustekinumab) injection Sucraid™ (sacrosidase) oral solution
5/19/2009
4/24/2009
9/25/2009
11/20/2008
Tracleer® (bosentan) tablets
8/7/2009
Vibativ™ (telavancin) injection Visicol® (sodium phosphate, dibasic anhydrous and sodium phosphate, monobasic, monohydrate) tablets Xenazine® (tetrabenazine) tablets
9/11/2009
10/13/2009
Medication guide, elements to assure safe use, implementation system Medication guide, communication plan, elements to assure safe use, implementation system Medication guide, communication plan Medication guide, communication plan Medication guide, communication plan Communication plan, elements to assure safe use, implementation system Medication guide, elements to assure safe use, implementation system Medication guide, communication plan Medication guide, communication plan
8/15/2008
Medication guide, communication plan
healthcare practitioners have multiple sites of practice, the ETASU must be able to accommodate the many treatment sites of practice for healthcare practitioners that have enrolled in the REMS program. Effective ETASU programs allow the patient to access the drug in the most convenient treatment sites of care available to him or her, while maintaining elements of the REMS across those sites.
Depending on the risk mitiga-
tion requirements of each drug to
achieve ETASU approval, REMS
programs can involve the en-
rollment of distributors who at-
test they will only sell to those
healthcare sites that have attested
that they will dispense or make
available (in the case of facilities)
drugs to healthcare practitioners
who have enrolled in the REMS.
In some cases, those healthcare
practitioners further attest that
they will treat patients who have
agreed to attest to doing their part
in maintaining the maximal risk/
benefit of the drug in their case.
Often, all aspects of the ETASU are
supported by data systems that al-
low pharmacoepidemiologic stud-
ies to be completed to determine if
aberrant patterns of drug use exist,
and if those patterns are decreas-
ing the risk/benefit profile of the
drug. ETASU requirements may
include restrictions on accessing a
drug based on the following:
References:
Archives