(Part 1)
(Part 2)
Is there a "medical reason" for these guidelines or isn't there?
The CBC has interviewed Dr. Norman at least six times, and each time she questions why Canada has chosen to only allow doctors to dispense this drug, and not pharmacists. Dr. Norman calls this behaviour "strange and bizarre", "highly unusual", an "absolutely inexplicable regulation" and "demeaning".
Decide for yourself.
All the information and links below are from the US's Food and Drug Administration's (FDA) Approved Risk Evaluation and Mitigation Strategies (REMS). (All emphasis in red added)
(Part 2)
"I cannot understand the need for that. There isn't a medical reason we would need that." Dr. Wendy NormanSo let's look at these strict accessibility guidelines for RU-486 (mifepristone), based on the US example, a country ten times the size of Canada.
Is there a "medical reason" for these guidelines or isn't there?
The CBC has interviewed Dr. Norman at least six times, and each time she questions why Canada has chosen to only allow doctors to dispense this drug, and not pharmacists. Dr. Norman calls this behaviour "strange and bizarre", "highly unusual", an "absolutely inexplicable regulation" and "demeaning".
Decide for yourself.
All the information and links below are from the US's Food and Drug Administration's (FDA) Approved Risk Evaluation and Mitigation Strategies (REMS). (All emphasis in red added)
I. GOAL
The goal of the Mifeprex
REMS is to mitigate the risk of serious complications associated with Mifeprex
by:
a) Requiring healthcare
providers who prescribe Mifeprex to be certified in the Mifeprex REMS Program.
b) Ensuring that Mifeprex
is only dispensed in certain healthcare settings by or under the supervision of a
certified prescriber.
c) Informing patients
about the risk of serious complications associated with Mifeprex
II. REMS ELEMENTS
A. Elements to Assure Safe
Use
1. Healthcare providers who
prescribe Mifeprex must be specially certified.
a. To become specially
certified to prescribe Mifeprex, healthcare providers must:
i. Review the Prescribing
Information for Mifeprex.
ii. Complete the
Prescriber Agreement Form. By signing the Prescriber agreement Form, prescribers
agree that:
1) They have the following
qualifications:
a) Ability to assess the
duration of pregnancy accurately
b) Ability to diagnose
ectopic pregnancies
c) Ability to provide
surgical intervention in cases of incomplete abortion or severe
bleeding, or to have made plans to provide such care through others, and
ability to assure patient access to medical facilities equipped to
provide blood transfusions and resuscitation, if necessary.
2) They will follow the
guidelines for use of Mifeprex (see b.i-v below).
b. As a condition of
certification, healthcare providers must follow the guidelines for
use of Mifeprex described
below:
i. Review the Patient
Agreement Form with the patient and fully explain the risks of the Mifeprex treatment
regimen. Answer any questions the patient may have prior to receiving
Mifeprex.
ii. Sign the Patient
Agreement Form and obtain the Patient’s signature on the Form
iii. Provide the patient
with a copy of the Patient Agreement Form and Medication Guide.
iv. Place the signed
Patient Agreement Form in the patient's medical record.
v. Record the serial
number from each package of Mifeprex in each patient’s record.
vi. Report any deaths to
Danco Laboratories, identifying the patient by a nonidentifiable reference and the serial
number from each package of Mifeprex.
c. Danco Laboratories must:
i. Ensure that healthcare
providers who prescribe Mifeprex are specially certified in accordance with the
requirements described above and de-certify healthcare providers who do not
maintain compliance with certification requirements
ii. Provide the
Prescribing Information and Prescriber Agreement Form to healthcare providers who
inquire about how to become certified.
The following materials are
part of the REMS and are appended:
• Prescriber Agreement
Form
• Patient Agreement Form
2. Mifeprex must be
dispensed to patients only in certain healthcare settings, specifically clinics,
medical offices, and hospitals, by or under the supervision of a certified prescriber.
a. Danco Laboratories must:
i. Ensure that Mifeprex is
available to be dispensed to patients only in clinics, medical offices and
hospitals by or under the supervision of a certified prescriber.
ii. Ensure that Mifeprex
is not distributed to or dispensed through retail pharmacies or other
settings not described above.
3. Mifeprex must be
dispensed to patients with evidence or other documentation of safe
use conditions.
a. The patient must sign a
Patient Agreement Form indicating that she has:
i. Received, read and been
provided a copy of the Patient Agreement Form.
ii. Received counseling
from the prescriber regarding the risk of serious complications associated
with Mifeprex.
B. Implementation System
1. Danco Laboratories must
ensure that Mifeprex is only distributed to clinics, medical offices and hospitals by or under
the supervision of a certified prescriber by:
a. Ensuring that
distributors who distribute Mifeprex comply with the program requirements for
distributors. The distributors must:
i. Put processes and
procedures in place to:
a. Complete the healthcare
provider certification process upon receipt of the Prescriber Agreement form.
b. Notify healthcare
providers when they have been certified by the Mifeprex REMS Program.
c. Ship Mifeprex only to
clinics, medical offices, and hospitals identified by certified prescribers in
the signed Prescriber Agreement Form.
d. Not ship Mifeprex to
prescribers who become de-certified from the Mifeprex Program.
e. Provide the Prescribing
Information and Prescriber Agreement Form to healthcare providers who
(1) attempt to order Mifeprex and are not yet certified, or (2) inquire
about how to become certified.
ii. Put processes and
procedures in place to maintain a distribution system that is secure, confidential and
follows all processes and procedures, including those for storage, handling,
shipping, tracking package serial numbers, proof of delivery and controlled
returns of Mifeprex.
iii. Train all relevant
staff on the Mifeprex REMS Program requirements.
iv. Comply with audits by
Danco Laboratories, FDA or a third party acting on behalf of Danco
Laboratories or FDA to ensure that all processes and procedures are in place and
are being followed for the Mifeprex REMS Program. In addition,
distributors must maintain appropriate documentation and make it available for
audits.
b. Ensuring that
distributors maintain secure and confidential distribution records of
all shipments of Mifeprex.
2. Danco Laboratories must
monitor distribution data to ensure compliance with the REMS Program.
3. Danco Laboratories must
audit new distributors within 90 calendar days after the distributor
is authorized to ensure that
all processes and procedures are in place and functioning to support the requirements of the Mifeprex REMS Program. Danco Laboratories will take steps to address distributor
compliance if noncompliance is identified.
4. Danco Laboratories must
take reasonable steps to improve implementation of and compliance with the requirements of
the Mifeprex REMS Program based on monitoring and assessment of the Mifeprex REMS Program.
5. Danco Laboratories must
report to FDA any death associated with Mifeprex whether or not considered drug-related, as
soon as possible but no later than 15 calendar days from the initial receipt of the information
by the applicant. This requirement does not affect the applicant's other reporting and
follow-up requirements under FDA regulations.
C. Timetable for Submission
of Assessments
Danco Laboratories must
submit REMS assessments to FDA one year from the date of the initial approval of the REMS
(06/08/2011) and every three years thereafter. To facilitate
inclusion of as much information as
possible while allowing reasonable time to prepare the submission,
the reporting interval covered
by each assessment should conclude no earlier than 60 days before the submission date for that
assessment. Danco Laboratories must submit each assessment so that it will be received by the FDA
on or before the due date.
_________________________________________________________________________
What do participants need to know?
What do participants need to know?
Healthcare Providers who
prescribe and dispense Mifeprex must To be able to prescribe:
- Review the drug’s prescribing information.
- Complete and submit the Prescriber Agreement Form.
Healthcare Providers who prescribe and dispense Mifeprex must Before dispensing
- Review the Patient Agreement Form with the patient and fully explain the risks of the Mifeprex treatment regimen.
- Provide the patient with the Medication Guide.
- Complete the Patient Agreement Form with the patient. Provide a completed copy of the form to the patient and retain a completed copy in the patient’s record.
- Complete the Patient Agreement Form with the patient. Provide a completed copy of the form to the patient and retain a completed copy in the patient’s record.
Patients who are prescribed
Mifeprex Before receiving
- Review the Patient Agreement Form.
- Complete the Patient Agreement Form with the prescriber.
- Receive counseling from the prescriber on the risks associated with Mifeprex.
Distributors that
distribute Mifeprex must To be able to distribute
- Establish processes and procedures to ensure that the drug is distributed only to clinics, medical offices, and hospitals identified by certified healthcare providers.
- Establish processes and procedures to maintain a distribution system that is secure and confidential.
- Establish processes and procedures to maintain a system for proper storage, handling, shipping, tracking package serial numbers, proof of delivery and controlled returns of Mifeprex.
- Train all relevant staff involved in distribution of Mifeprex on the REMS Program requirements.
Distributors that distribute Mifeprex must At all times
- Maintain confidential distribution records of all shipments of Mifeprex.
- Cooperate with audits carried out by the application holder to ensure that all processes and procedures are in place and are being followed.
Patient must fill out this
form (1 page):
Doctor must fill out this form (2 page):
http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2016-03-29_Prescriber_Agreement_Form.pdf
Medication guide for
patient (4 pages)
FDA warning:
"You should not buy Mifeprex over the Internet because you will bypass important safeguards designed to protect your health (and the health of others).
Mifeprex has special safety restrictions on how it is distributed to the public. Also, drugs purchased from foreign Internet sources are not the FDA-approved versions of the drugs, and they are not subject to FDA-regulated manufacturing controls or FDA inspection of manufacturing facilities.
To learn more about buying drugs safely, please see Buying Prescription Medicines Online: A Consumer Safety Guide"
Mifepristone U.S. Postmarketing Adverse Events Summary through 04/30/2011 (including deaths, hospitalizations, blood transfusions, ectopic pregnancies and infections):
