Forgot Your Password?
Complete Story
 

New Requirement to Dispense Accutane

Pregnancy Prevention Program for Women on Accutane enhanced.

New Requirement to Dispense Accutane
Teresa Clement,
B.S. Candidate, University of Cincinnati, and OPA extern


Roche, the manufacturer of Accutane® (isotretinoin), has enhanced the Pregnancy Prevention Program for Women on Accutane with a new program called System to Manage Accutane Related Teratogenicity (SMARTTM). Accutane is an effective treatment for severe recalcitrant nodular (cystic) acne that has not responded to other therapies. Accutane is teratogenic; therefore SMART is designed to ensure that female patients are not pregnant while taking this medication.

Prescribing physicians are required to enroll in the SMART program. Upon agreement to the terms, they will receive yellow Accutane Qualification Stickers. As of April 10, 2002, only prescriptions with the yellow stickers will be in compliance with the product label. The prescription must be filled within seven days of the qualification date on the sticker. Therefore, telephone or computerized Accutane prescriptions are invalid. Refills require a new prescription with the yellow Accutane Qualification Sticker attached, and no more than a 30-day supply can be dispensed at a time. Also, included with the product label, pharmacists must provide a copy of the Accutane Medication Guide to all patients with each prescription.

For the female patient to receive her first Accutane prescription, she must:
1. have two negative pregnancy tests - the first as a screening test and the second as a confirmatory test that will be administered during the first five days of her next menstrual period;
2. select and commit to using two effective forms of birth control simultaneously one month prior to treatment, during treatment, and for one month after stopping treatment;
3. read and sign an informed consent agreement explaining the risk of potential birth defects associated with Accutane;
4. learn about and be encouraged to enroll in the Accutane Survey, a system to track female Accutane patients, learn about their experiences with pregnancy prevention efforts and determine their pregnancy status.

For each of the following months of therapy, the female patient must have a negative pregnancy test and receive contraception counseling from the physician.

Male patients must also sign consent agreements and have a yellow Accutane Qualification Sticker attached to their Accutane prescription.
For more information, visit the website http://www.rocheusa.com.
< Back | Printer Friendly Page
Get OPA Events via RSS

Events

 September 2014 
SMTWTFS
 123456
78910111213
1415161718
1920
2122232425
26
27
282930    
September 25, 2014
7:30AM-5:15PM

APhA's Diabetes Care Certificate Training Program for Pharmacists

OPA office- 2674 Federated Blvd., Columbus, OH 43235

September 26, 2014
9:00AM-1:30PM

Ohio Pharmacy Advocacy Forum

Northeast Ohio Medical University, University Hall, 4209 State Route 44, Rootstown, OH 44272

October 8, 2014
7:30AM-5:15PM

APhA's Delivering MTM Services: A Certificate Training Program for Pharmacists

OPA office- 2674 Federated Blvd., Columbus, OH 43235

October 29, 2014

Live Webinar: Required OSHA Training for Immunizing Pharmacists 2 p.m. & 6 p.m.

October 30, 2014
11:00AM

Live Webinar: Required OSHA Training for Immunizing Pharmacists 11 a.m.