Medication abortion: Advocating for mifepristone dispensing by pharmacists

Medication abortion consisting of an oral regimen of mifepristone and misoprostol has been available in the United States since 2000 when mifepristone was approved by the Food and Drug Administration (FDA) for this indication [[1]Mifeprex REMS Study GroupSixteen years of overregulation: time to unburden Mifeprex.N Eng J Med. 2017; 376: 790-794https://doi.org/10.1056/NEJMsb1612526Crossref PubMed Scopus (49) Google Scholar]. Special access and use restrictions have been imposed by the FDA since initial approval, and in 2008 mifepristone was transitioned into a Risk Evaluation and Mitigation Strategy (REMS) program. REMS programs are designed to ensure that benefits outweigh the risks for medications with serious safety concerns, and often strictly regulate access [[2]Mifepristone Shared System REMSApproved risk evaluation and mitigation strategies (REMS).2019Google Scholar]. However, serious adverse events associated with medication abortion are rare. In fact, data indicate that the background risk of pregnancy-related death among pregnant women in the United States who proceed to live birth is approximately 14 times higher than the estimated mifepristone-associated mortality [[1]Mifeprex REMS Study GroupSixteen years of overregulation: time to unburden Mifeprex.N Eng J Med. 2017; 376: 790-794https://doi.org/10.1056/NEJMsb1612526Crossref PubMed Scopus (49) Google Scholar,[3]Raymond EG Grimes DA. The comparative safety of legal induced abortion and childbirth in the United States.Obstet Gynecol. 2012; 119: 215-219https://doi.org/10.1097/AOG.0b013e31823fe923Crossref PubMed Scopus (189) Google Scholar]. In 2016, the labeling for mifepristone was updated by the FDA, removing requirements for in-person follow up and physician-only prescribing. Three REMS elements remain and stipulate that providers must become certified to prescribe mifepristone, it must be dispensed in a clinic, medical office, or hospital, and patient counseling must be acknowledged on the Patient Agreement Form [[2]Mifepristone Shared System REMSApproved risk evaluation and mitigation strategies (REMS).2019Google Scholar]. In July 2020, a federal court ruled that the FDA must temporarily suspend the REMS regulation to allow contactless dispensing (i.e., clinic mails mifepristone) in response to the COVID-19 pandemic [[4](Civil Action No. TDC-20-1320) United States District Court, District of Maryland. Civil Action No. TDC-20-1320, 2020-07-13_pi_order_dckt_92_0.pdf (aclu.org); 2020 (accessed 30 March 2021).Google Scholar]. However, in January 2021, the Supreme Court reinstated restrictions requiring in person dispensing at the clinic site. Most recently, in April of 2021, the FDA completed an analysis which concluded there were no “serious safety concerns occurring with medical abortion as a result of modifying the in-person dispensing requirement during the COVID-19 pandemic.” [[5]FDA Response to ACOG 2021. https://www.aclu.org/letter/fda-response-acog-april-2021 (accessed 22 April 2021).Google Scholar] Based on this, the FDA indicated that enforcement of the in-person dispensing requirement would be suspended throughout the remainder of the COVID-19 public health emergency, allowing mifepristone to be mailed from a clinic or mail-order pharmacy. This model of contactless dispensing will likely facilitate access to medication abortion, but presents another interesting question – Why prohibit pharmacists, who are experts regarding medication use and safety, from purchasing, stocking, and dispensing mifepristone? Pharmacists are highly trained health care professionals, completing a doctorate program which prepares them for medication dispensing and advanced clinical practices, such as prescribing hormonal contraception, HIV pre-exposure prophylaxis (PrEP), naloxone, therapies for chronic disease management, and more [[6]Pharmacist prescribing: statewide protocols and more. https://naspa.us/resource/swp/; 2018 (accessed 30 March 2021).Google Scholar,[7]Weeks G George J Maclure K Stewart D. Non-medical prescribing versus medical prescribing for acute and chronic disease management in primary and secondary care.Cochrane Database Syst Rev. 2016; 11CD011227https://doi.org/10.1002/14651858.CD011227.pub2Crossref PubMed Scopus (47) Google Scholar]. Mifepristone pharmacy dispensing has already been piloted in a research study, with data indicating pharmacist dispensing was effective and acceptable to patients, with a low prevalence of adverse events [[8]Grossman D Baba C Kaller S Biggs A Raifman S Gurazada T et al.Medication abortion with pharmacist dispensing of mifepristone.Obstet Gynecol. 2021; 137: 613-622https://doi.org/10.1097/AOG.0000000000004312Crossref PubMed Scopus (4) Google Scholar]. Additionally, pharmacies are already incorporated into many aspects of medication abortion care. Even though pharmacies currently cannot stock or dispense mifepristone, patients often visit a pharmacy to receive additional supportive abortion care, such as misoprostol, antiemetics, analgesics, menstrual products and/or contraception. Community pharmacies are the most frequently visited health care setting, with over 90% of the US population living within 2 miles of a community pharmacy [[1]Mifeprex REMS Study GroupSixteen years of overregulation: time to unburden Mifeprex.N Eng J Med. 2017; 376: 790-794https://doi.org/10.1056/NEJMsb1612526Crossref PubMed Scopus (49) Google Scholar,[9]Munger MA Sundwall DN Feehan M. Integrating family medicine and community pharmacy to improve patient access to quality primary care and enhance health outcomes.Am J Pharm Ed. 2018; 82 (https:doi.org/10.5688/ajpe6572): 6572Crossref PubMed Scopus (2) Google Scholar]. Permitting patients to obtain mifepristone through a widely dispersed network of community pharmacies will likely improve access [[10]Raifman S, Orlando M, Rafie S, Grossman D. Medication abortion: potential for improved patient access through pharmacies. J Am Pharm Assoc.58(4):377-81.Google Scholar]. In fact, other developed countries such as Australia and Canada successfully allow mifepristone dispensing from community pharmacies [[11]Norman WV Soon JA. Requiring physicians to dispense mifepristone: an unnecessary limit on safety and access to medical abortion.CMAJ. 2016; 188: E429-E430Crossref PubMed Scopus (13) Google Scholar]. As a result, there has been widespread expansion of effective, safe, and economical medication abortion access in both urban and rural areas [12Grossman D Grindlay K Buchacker T Lane K Blanchard K Effectiveness and acceptability of medical abortion provided through telemedicine.Obstet Gynecol. 2011; 118: 296-303https://doi.org/10.1097/AOG.0b013e318224d110Crossref PubMed Scopus (92) Google Scholar, 13Grossman DA Grindlay K Buchacker T Potter JE Schmertmann CP. Changes in service delivery patterns after introduction of telemedicine provision of medical abortion in Iowa.Am J Public Health. 2013; 103: 73-78https://doi.org/10.2105/AJPH.2012.301097Crossref PubMed Scopus (51) Google Scholar, 14Grossman D Goldstone P. Mifepristone by prescription: a dream in the United States but reality in Australia.Contraception. 2015; 92: 186e189https://doi.org/10.1016/j.contraception.2015.06.014Abstract Full Text Full Text PDF Scopus (30) Google Scholar, 15Hyland P Raymond EG Chong E. A direct-to-patient telemedicine abortion service in Australia: retrospective analysis of the first 18 months.Aust N Z J Obstet Gynaecol. 2018; 58: 335-340https://doi.org/10.1111/ajo.12800Crossref PubMed Scopus (39) Google Scholar, 16Munro S Guilbert E Wagner MS Wilcox ES Devane C Dunn S et al.Perspectives among Canadian physicians on factors influencing implementation of mifepristone medical abortion: a national qualitative study.Ann Fam Med. 2020; 18: 413-421https://doi.org/10.1370/afm.2562Crossref PubMed Scopus (4) Google Scholar]. Utilization of mail-order pharmacies will further increase the number of pharmacies available to provide this aspect of abortion care, particularly in areas underserved by brick-and-mortar community pharmacies. Pharmacist dispensing is one potential path for patients to receive medication abortion and will be complementary to other established avenues of access (i.e., dispensing from the provider's office or clinic). Critics of pharmacist dispensed mifepristone have suggested that it may not be meaningful if only a small number of pharmacies choose to dispense mifepristone. Similar to other medical professions, there will be pharmacists who choose not to participate in abortion care for personal reasons. However, we feel that this potential limitation should not preclude pharmacy dispensing and argue that any increase in access for this highly restricted medication is positive and should be welcomed. Policies alone do not ensure successful implementation or high-quality care. A policy change would allow for pharmacist dispensing that could be effectively implemented with thoughtful planning and adequate resources. The pharmacy profession has learned many lessons from the recent implementation of other policies expanding access to reproductive health services in pharmacies, including pharmacist prescribing of emergency contraception or hormonal contraception and expanded contraceptive supplies [17Mody SK Rafie S Hildebrand M Oakley LP. Exploring emergency contraception prescribing by pharmacists in California.Contraception. 2019; 100: 464-467https://doi.org/10.1016/j.contraception.2019.08.012Abstract Full Text Full Text PDF PubMed Scopus (6) Google Scholar, 18Rafie S Cieri-Hutcherson NE Frame TR Griffin B Harris JB Horlen C et al.Pharmacists’ perspectives on prescribing and expanding access to hormonal contraception in pharmacies in the United States.Journal of Pharmacy Practice. 2021; 34: 230-238https://doi.org/10.1177/0897190019867601Crossref PubMed Scopus (15) Google Scholar, 19Nikpour G Allen A Rafie S Sim M Rible R Chen A. Pharmacy implementation of a new law allowing year-long hormonal contraception supplies.Pharmacy. 2020; 8: 165https://doi.org/10.3390/pharmacy8030165Crossref Google Scholar]. Uptake of a new medication or service may be slow if prescribers and patients are not aware that it is available, as demonstrated by infrequent use of ulipristal acetate, the most effective oral emergency contraceptive pill available in the United States [[20]Shigesato M Elia J Tschann M Bullock H Hurwitz E Wu YY et al.Pharmacy access to Ulipristal acetate in major cities throughout the United States.Contraception. 2018; 97 (PubMed PMID:29097224): 264-269https://doi.org/10.1016/j.contraception.2017.10.009Abstract Full Text Full Text PDF PubMed Scopus (17) Google Scholar,[21]Batur P Cleland K McNamara M Wu J Pickle S EC Survey GroupEmergency contraception: a multispecialty survey of clinician knowledge and practices.Contraception. 2016; 93 (Epub 2015/09/10PubMed PMID:26363429): 145-152https://doi.org/10.1016/j.contraception.2015.09.003Abstract Full Text Full Text PDF PubMed Scopus (41) Google Scholar]. Since pharmacists are currently prohibited from providing mifepristone, it is unlikely that medication abortion is covered in the standard curricula at all pharmacy schools. Practicing pharmacists routinely educate themselves regarding new drug therapies as a standard of professional education and practice, and could do so with mifepristone if formal education is lacking. Pharmacists may choose to develop their knowledge and skills related to medication abortion by completing continuing education programs [[22]Pharmacists' role in medication abortion, https://cmecalifornia.com/lms/[email protected]=%201&@activity.id=7154580; 2020 (accessed 30 March 2021).Google Scholar], or utilizing technical assistance tools such as communication templates, counseling guides, and referral resources [[23]Meeting reproductive health needs at the pharmacy, https://birthcontrolpharmacist.com/referrals/; 2021 (accessed 30 March 2021).Google Scholar,[24]Clinical resources: pharmacy forms and guides, https://birthcontrolpharmacist.com/resources/; 2021 (accessed 30 March 2021).Google Scholar]. Pharmacies and abortion providers can effectively partner to serve their communities. Finally, mifepristone will need to be stocked by all major prescription drug wholesalers and available for pharmacies to order, so that community pharmacies can, in turn, ensure that the medication is consistently maintained in stock. Pharmacist dispensed mifepristone should be broadly accessible and made available equitably across communities. While we aim for widespread implementation and access, we will recognize all successes and not be discouraged by challenges. We urge the FDA to make medication abortion more accessible by removing the current REMS restriction on mifepristone that prohibits pharmacist dispensing. Sally Rafie served as a consultant for GenBioPro. Rebecca H. Stone has no conflict of interest to report.

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