Isotretinoin (Page 5 of 11)

All Patients

Isotretinoin is contraindicated in patients who are pregnant. To receive isotretinoin all patients must meet all of the following conditions:

  • Must be enrolled with the iPLEDGE REMS by the prescriber
  • Must understand that life-threatening birth defects can occur with the use of isotretinoin by patients who can become pregnant
  • Must be reliable in understanding and carrying out instructions
  • Must sign a Patient Enrollment Form for Patients who cannot get Pregnant that contains warnings about the potential risks associated with isotretinoin
  • Must obtain the prescription within 7 days of the date of specimen collection for the pregnancy test for patients who can become pregnant
  • Must obtain the prescription within 30 days of the office visit for patients who cannot become pregnant
  • Must not donate blood while on isotretinoin and for one month after treatment has ended
  • Must not share isotretinoin with anyone, even someone who has similar symptoms

Patients Who Can Become Pregnant

Isotretinoin is contraindicated in patients who are pregnant. In addition to the requirements for all patients described above, patients who can become pregnant must meet the following conditions:

  • Must NOT be pregnant or breast-feeding
  • Must comply with the required pregnancy testing at a CLIA-certified laboratory
  • Must obtain the prescription within 7 days of the date of specimen collection for the pregnancy test
  • Must be capable of complying with the mandatory contraceptive measures required for isotretinoin therapy, or commit to continuous abstinence not having any sexual contact with a partner that could result in pregnancy, and understand behaviors associated with an increased risk of pregnancy
  • Must understand that it is the patient who can become pregnant responsibility to avoid pregnancy one month before, during and one month after isotretinoin therapy
  • Must have signed an additional Patient Enrollment Form for Patients who can get Pregnant, before starting isotretinoin, that contains warnings about the risk of potential birth defects if the fetus is exposed to isotretinoin
  • Must access the iPLEDGE system via the internet (www.ipledgeprogram.com) or telephone (1-866-495-0654), before starting isotretinoin, on a monthly basis during therapy, and one month after the last dose to answer questions on the program requirements and to enter the patient’s two chosen forms of contraception
  • Must have been informed of the purpose and importance of providing information to the iPLEDGE REMS should the patient become pregnant while taking isotretinoin or within one month of the last dose

Pharmacists

To dispense isotretinoin, pharmacies must be enrolled and activated with the pregnancy risk management program iPLEDGE.

The Responsible Site Pharmacist must enroll the pharmacy by signing and returning the completed Pharmacy Enrollment Form. After enrolling, the Responsible Site Pharmacist can only activate the pharmacy enrollment by affirming that they meet requirements and will comply with all iPLEDGE requirements by attesting to the following points:

  • I know the risk and severity of fetal injury/birth defects from isotretinoin.
  • I will train all pharmacists who participate in the filling and dispensing of isotretinoin prescriptions on the iPLEDGE REMS requirements.
  • I will comply and seek to ensure all pharmacists who participate in the filling and dispensing of isotretinoin prescriptions comply with the iPLEDGE REMS requirements described in the booklet entitled Pharmacist Guide, specifically the “Key Information for Pharmacists” section including the following dispensing information:
    Prescriptions must be obtained no later than the “Do Not Dispense To After” date, and if not obtained, then the RMA must be reversed in the iPLEDGE REMS system and the product returned to inventory.
  • I understand and will comply with Non-Compliance Action Policy.
  • I will only obtain isotretinoin capsules product from only iPLEDGE enrolled wholesalers.
  • I will not sell, buy, borrow, loan or otherwise transfer isotretinoin in any manner to or from another pharmacy.
  • I will return to the manufacturer (or delegate) any unused product if the pharmacy is deactivated by the iPLEDGE REMS or if the pharmacy chooses to not reactivate annually.
  • I will not fill isotretinoin for any party other than a qualified patient.
  • I will comply with the audits by the iPLEDGE Sponsors or third party acting on behalf of the iPLEDGE Sponsors to ensure that all processes and procedures are in place and being followed for the iPLEDGE REMS

To dispense isotretinoin, the pharmacist must:

1)
be trained by the Responsible Site Pharmacist concerning the iPLEDGE REMS requirements.
2)
obtain authorization from the iPLEDGE REMS via the internet (www.ipledgeprogram.com), or telephone (1-866-495-0654) for every isotretinoin prescription. Authorization signifies that the patient has met all program requirements and is qualified to receive isotretinoin capsules.
3)
write the Risk Management Authorization (RMA) number on the prescription.

Isotretinoin capsules must only be dispensed:

  • in no more than a 30-day supply
  • with an isotretinoin capsules Medication Guide
  • after authorization from the iPLEDGE REMS
  • prior to the “do not dispense to patient after” date provided by the iPLEDGE system (within 30 days of the office visit for patients who cannot become pregnant and within 7 days of the date of specimen collection for patients who can become pregnant)
  • with a new prescription for refills and another authorization from the iPLEDGE REMS (No automatic refills are allowed)

An isotretinoin capsules Medication Guide must be given to the patient each time isotretinoin capsules is dispensed, as required by law. This isotretinoin capsules Medication Guide is an important part of the risk management program for the patients.

Isotretinoin capsules must not be prescribed, dispensed or otherwise obtained through the internet or any other means outside of the iPLEDGE REMS. Only FDA-approved isotretinoin capsules products must be distributed, prescribed, dispensed, and used. Patients must obtain isotretinoin capsules prescriptions only at US licensed pharmacies.

A description of the iPLEDGE REMS educational materials available with iPLEDGE is provided below. The main goal of these educational materials is to explain the iPLEDGE REMS requirements and to reinforce the educational messages.

1)
Prescriber Guide includes: isotretinoin teratogenic potential, information on pregnancy testing, and the method to complete a qualified isotretinoin capsules prescription.
2)
Pharmacist Guide includes: isotretinoin teratogenic potential and the method to obtain authorization to dispense an isotretinoin prescription.
3)
The iPLEDGE REMS is a systematic approach to comprehensive patient education about their responsibilities and includes education for contraception compliance and reinforcement of educational messages. The iPLEDGE REMS includes information on the risks and benefits of isotretinoin capsules which is linked to the Medication Guide dispensed by pharmacists with each isotretinoin prescription.
4)
The Fact Sheet for the iPLEDGE REMS includes information on the iPLEDGE REMS, the product indications and safety information. This handout is provided to both the patient who can become pregnant and the patient who cannot become pregnant. The Patient Enrollment Form for Patients who cannot get Pregnant is also provided to all patients.
5)
Patients who can become pregnant are provided with a Guide for Patients who Can Get Pregnant , which contains information on isotretinoin therapy including precautions and warnings, and a second Patient Enrollment Form for Patients who can get Pregnant concerning birth defects, and a toll-free line which provides isotretinoin capsules information in two languages.
6)
The booklet for patients who can become pregnant, Contraception Counseling Guide , includes a referral program that offers patients free contraception counseling, reimbursed by the manufacturer, by a reproductive specialist and a second Patient Enrollment Form for Patients who can get Pregnant concerning birth defects.
7)
The Guide for Patients Who Can Get Pregnant outlines the effectiveness of the approved contraception options. (see Information for Patients).

General

Although an effect of isotretinoin capsules on bone loss is not established, physicians should use caution when prescribing isotretinoin capsules to patients with a genetic predisposition for age-related osteoporosis, a history of childhood osteoporosis conditions, osteomalacia, or other disorders of bone metabolism. This would include patients diagnosed with anorexia nervosa and those who are on chronic drug therapy that causes drug-induced osteoporosis/osteomalacia and/or affects vitamin D metabolism, such as systemic corticosteroids and any anticonvulsant.

Patients may be at increased risk when participating in sports with repetitive impact where the risks of spondylolisthesis with and without pars fractures and hip growth plate injuries in early and late adolescence are known. There are spontaneous reports of fractures and/or delayed healing in patients while on therapy with isotretinoin capsules or following cessation of therapy with isotretinoin capsules while involved in these activities. While causality to isotretinoin capsules has not been established, an effect must not be ruled out.

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