Provision of Mifeprex can be easily integrated into your standard office practice.
Administered in the privacy of a doctor's office, clinic or hospital, Mifeprex is a safe and effective method for early pregnancy termination. Mifeprex is only available direct from Danco Laboratories' distributor. To provide Mifeprex, you must first establish an account with the distributor. For information and instructions on establishing an account click here.
Provider Qualifications and Guidelines
Under Federal law, Mifeprex must be provided by or under the supervision of a physician who meets the following qualifications:
- Ability to assess the duration of pregnancy accurately.
- Ability to diagnose ectopic pregnancies.
- Ability to provide surgical intervention in cases of incomplete abortion or severe bleeding, or have made plans to provide such care through others, and are able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.
- Has read and understood the Prescribing Information of Mifeprex.
In addition to these qualifications, you must provide Mifeprex in a manner consistent with the following guidelines.
- Under Federal law, each patient must be provided with a Medication Guide. You must fully explain the procedure to each patient, provide her with a copy of the Medication Guide and Patient Agreement, give her an opportunity to read and discuss them, obtain her signature on the Patient Agreement, and sign it yourself.
- The patient's follow-up visit at approximately 14 days is very important to confirm that a complete termination of pregnancy has occurred and that there have been no complications. You must notify Danco Laboratories in writing as discussed in the Package Insert under the heading Dosage and Administration in the event of an on-going pregnancy which is not terminated subsequent to the conclusion of the treatment procedure.
- While serious adverse events associated with the use of Mifeprex are rare, you must report any hospitalization, transfusion or other serious event to Danco Laboratories, identifying the patient solely by package serial number to ensure patient confidentiality.
- Each package of Mifeprex has a serial number. As part of maintaining complete records for each patient, you must record this serial number in each patient's record.
For additional information on providing Mifeprex please also review the letters below.
- Dear Health Care Provider 7-19-05
- Dear Health Care Professional 11-15-04
- Dear Emergency Room Director 11-15-04
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