New guidelines for dispensing Mifegymiso®
ACP Council approved guidelines for dispensing Mifegymiso® in Alberta at its June 2017 meeting.
Among the guidelines is a restriction that pharmacists must not prescribe Mifegymiso. This restriction applies to both adapting prescriptions and prescribing with additional prescribing authorization. Those who choose not to dispense Mifegymiso due to moral objection should refer to ACP’s Code of Ethics and the section on conscientious objection in the guideline.
Nese Yuksel, Professor, Faculty of Pharmacy and Pharmaceutical Sciences at the University of Alberta, has prepared the following information document. Pharmacists and pharmacy technicians who plan to dispense Mifegymiso are strongly encouraged to review this article and complete the on-line training program.
Mifegymiso® : Information for Pharmacists
Nese Yuksel, BScPharm, PharmD
Professor, Faculty of Pharmacy and Pharmaceutical Sciences
Mifegymiso®, a combination product of mifepristone and misoprostol, was approved by Health Canada in 2015 for early medical abortion, and became available in Canada in January, 2017. Mifepristone is currently available in over 60 countries. Effective immediately, Alberta pharmacists can dispense Mifegymiso® directly to patients in accordance to the ACP’s Standards of Practice for Pharmacists and Pharmacy Technicians. As per ACP’s guidelines, pharmacists must not prescribe Mifegymiso®.
What is Mifegymiso®?
Mifepristone is a potent progesterone receptor antagonist; it blocks progesterone receptors directly in the uterus and prevents the endometrium from supporting an embryo, causing endometrial degeneration and uterine contractility. Misoprostol is a synthetic prostaglandin analogue and will cause cervical ripening and uterine contractions. In Canada, Mifegymiso® is indicated for a medical termination of an intra-uterine pregnancy up to 49 days gestation (from the first day of the last menstrual period). However, it is considered to be effective up to 70 days gestation.
How is Mifegymiso® taken?
The mifepristone tablet is taken orally, while the misoprostol tablets are administered buccally. On day one, the mifepristone 200 mg tablet is taken orally with water. The woman can take this dose at home. It is no longer required that the woman needs to ingest the mifepristone dose in the presence of a prescriber. On day two or three (about 24 – 48 hours after taking the mifepristone), two tablets of misoprostol 200 μg are placed on EACH side of the mouth between the cheeks and gums (total of 4 tablets or 800 μg). The tablets are left in place for 30 minutes and then the remaining fragments can be swallowed with a glass of water. Women should be advised to rest for a few hours after taking the misoprostol. On days seven to 14, women must follow-up with their physician to confirm that the abortion has been successful.
What should the woman expect after taking Mifegymiso®?
The pregnancy is passed from the uterus within two to 24 hours after taking Mifegymiso®. The woman should expect cramping, abdominal pain and vaginal bleeding that will be heavier than their usual period that can last two to four hours. However, women should be advised that if they experience heavy bleeding (defined as soaking two thick sanitary pads every two hours) or have significant abdominal pain, they should contact their health care provider right away. Other common side effects include nausea/vomiting, breast tenderness, hot flushes/chills, dizziness/fainting, diarrhea and fatigue. Most of these side effects will slowly go away over a few days. Women should seek additional help if they feel ill with severe nausea/vomiting, diarrhea, or a high fever.
What are the requirements to dispense Mifegymiso®?
Though training is no longer mandated by Health Canada, pharmacists who will be dispensing Mifegymiso® are encouraged to take the Medical Abortion Training Program available as an online course through the Society of Obstetricians and Gynecologists. Pharmacists are not required to dispense Mifegymiso®, especially if it is against their moral beliefs. However, they should assist the woman in finding another pharmacist who will dispense the product. It is very important that the woman be referred in the appropriate time frame.
When can women start using other contraception after taking Mifegymiso®?
The return to ovulation once the Mifegymiso® has been taken is relatively quick (as quickly as eight days). Women can start using a hormonal contraceptive soon after the misoprostol dose. For intrauterine devices, the woman should wait until the abortion has been confirmed.
Costescu D et al. Medical Abortion. Clinical Practice Guidelines. J Obstet Gyaecol Can. 2016 June;38(4):366-389.
Soon JA, Costescu D, Guilbert E. Medications used in evidence-based regimens for medical abortion: An overview. J Obstet Gynaecol Can 2016;38(7):636-45.
Dispensing Mifegymiso®: Guidance for Pharmacy Professionals Who Are Dispensing Mifegymiso®. Ontario College of Pharmacists. May 19, 2017.
Important Information on Mifegymiso® (mifepristone and misoprostol tablets) Canadian Distribution and Administration Program. Celopharma Inc. May 18, 2017.
Mifegymiso® Product Monograph Including Patient Medication Information. Celopharmac Inc. Date of Revision: October 21, 2016. https://pdf.hres.ca/dpd_pm/00036826.PDF. Last accessed June 27, 2017.