Pharmacies that dispense isotretinoin may notice changes to the iPLEDGE REMS program in the coming months. After considering advice from an advisory committee and public feedback, the FDA is requiring isotretinoin manufacturers to make changes to the iPLEDGE REMS to minimize burden on patients, pharmacies, and prescribers, while also maintaining the safe use of the drug. FDA has posted an FAQ and details on the changes on its website. Pharmacists and pharmacy staff need to know that under certain circumstances, home pregnancy tests are now allowed and that this may change the demand for OTC pregnancy tests among patients taking isotretinoin. Offering tests for sale at prescription pickup may help patients adhere to pregnancy testing requirements.
NCPA
