"No Big Deal": A Qualitative Study of Pharmacists' Perspectives on Dispensing Mifepristone for Medication Abortion.

INTRODUCTION: Until December 2021, the United States Food and Drug Administration impeded abortion access by restricting pharmacists from dispensing mifepristone, one of two drugs used in medication abortion. This study aimed to explore pharmacists' perspectives on dispensing mifepristone. METHODS: We conducted semistructured interviews with pharmacists before and after participating in a pilot project where mifepristone was dispensed from their pharmacies. We thematically coded all interview transcripts, then summarized emergent themes related to pharmacists' support, comfort, experiences, and concerns around dispensing mifepristone. RESULTS: Between May 2018 and July 2020, we interviewed 29 pharmacists (22 at baseline and 15 at follow-up, with 8 completing both interviews) from 5 pharmacies. At both baseline and follow-up, interviewees strongly supported pharmacists dispensing mifepristone, feeling it would improve quality of care by providing more convenient medication abortion access and streamlined service delivery and take advantage of pharmacists' expertise and availability. All pharmacists interviewed at follow-up reported dispensing mifepristone except two who were willing but did not have the opportunity. Pharmacists experienced few challenges dispensing mifepristone. Their main concern was perceived discomfort that other pharmacists and pharmacy staff may experience, particularly in conservative areas or small pharmacies where pharmacists' refusal to dispense mifepristone could impede abortion access. CONCLUSIONS: Most pharmacists supported dispensing mifepristone and were comfortable doing so after education on mifepristone and medication abortion. They dispensed mifepristone without difficulty, in a similar process as dispensing other medications. With the recent removal of U.S. Food and Drug Administration restrictions prohibiting it, our findings support the feasibility of pharmacists dispensing mifepristone.

Pharmacists' knowledge, perspectives, and experiences with mifepristone dispensing for medication abortion.

BACKGROUND: The U.S. Food and Drug Administration (FDA) restricts dispensing of mifepristone for medication abortion to certified health care providers at clinical facilities, thus prohibiting pharmacist dispensing. Allowing mifepristone dispensing by pharmacists could improve access to medication abortion. OBJECTIVE: To assess the feasibility of pharmacists dispensing mifepristone to patients who have undergone evaluation for eligibility and counseling for medication abortion by a clinician. METHODS: Before providing a study training on medication abortion, we administered baseline surveys to pharmacists who participated in a multisite mifepristone-dispensing intervention. The survey assessed medication abortion knowledge-using a 15-item score-and perceptions about the benefits and challenges of the model. We administered follow-up surveys in the study's final month that also assessed the pharmacists' satisfaction and experiences with mifepristone dispensing. To investigate the association of the study intervention with the pharmacists' knowledge, perceptions, and experiences dispensing mifepristone, we conducted multivariable linear regression analyses using generalized estimating equation models, accounting for clustering by individual. RESULTS: Among the 72 pharmacists invited from 6 pharmacies, 47 (65%) completed the baseline surveys, and 56 (78%) received training. At the study's end (mean 18 months later), 43 of the 56 pharmacists who received training (77%) completed the follow-up surveys. At follow-up, 36 (83%) respondents were very or somewhat satisfied with mifepristone dispensing, and 24 (56%) reported experiencing no challenges dispensing mifepristone. Four (6%) of the 72 pharmacists invited objected to participating in mifepristone dispensing. In regression analyses, average knowledge scores, perceived ease of implementation, and level of support for the pharmacist-dispensing model were higher at follow-up (P < 0.001). CONCLUSION: Most pharmacists were willing to be trained, dispensed mifepristone with few challenges when given the opportunity, were satisfied with the model, and had higher knowledge levels at follow-up. Our findings support removal of FDA's restriction on pharmacist dispensing of mifepristone.

Medication Abortion With Pharmacist Dispensing of Mifepristone.

OBJECTIVE: To estimate effectiveness and acceptability of medication abortion with mifepristone dispensed by pharmacists. METHODS: We conducted a prospective cohort study at eight clinical sites and pharmacies in California and Washington State from July 2018 to March 2020. Pharmacists at participating pharmacies underwent a 1-hour training on medication abortion. We approached patients who had already been evaluated, counseled, and consented for medication abortion per standard of care. Patients interested in study participation gave consent, and the clinician electronically sent a prescription to the pharmacy for mifepristone 200 mg orally, followed 24-48 hours later by misoprostol 800 micrograms buccally. Participants were sent web-based surveys about their experience and outcomes on days 2 and 14 after enrollment and had routine follow-up with study sites. We extracted demographic and clinical data, including abortion outcome and adverse events, from medical records. We performed multivariable logistic regression to assess the association of pharmacy experience and other covariates with satisfaction. RESULTS: We enrolled 266 participants and obtained clinical outcome information for 262 (98.5%), of whom two reported not taking either medication. Of the 260 participants with abortion outcome information, 252 (96.9%) and 237 (91.2%) completed day 2 and 14 surveys, respectively. Complete medication abortion (primary outcome) occurred for 243 participants (93.5%, 95% CI 89.7-96.1%). Four participants (1.5%, 95% CI 0.4-3.9%) had an adverse event, none of which was serious or related to pharmacist dispensing. In the day 2 survey, 91.3% (95% CI 87.1-94.4%) of participants reported satisfaction with the pharmacy experience. In the day 14 survey, 84.4% (95% CI 79.1-88.8%) reported satisfaction with the medication abortion experience. Those reporting being very satisfied with the pharmacy experience had higher odds of reporting overall satisfaction with medication abortion (adjusted odds ratio 2.96, 95% CI 1.38-6.32). CONCLUSION: Pharmacist dispensing of mifepristone for medication abortion is effective and acceptable to patients, with a low prevalence of adverse events. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03320057.

Distance Traveled for an Abortion and Source of Care After Abortion.

OBJECTIVE: To examine the association between distance traveled for an abortion and site of postabortion care among low-income women. METHODS: We conducted a retrospective cohort study using claims data from 39,747 abortions covered by California's Medicaid program in 2011-2012. Primary outcomes were the odds of abortion-related visits to an emergency department (ED) and the original abortion site, and the secondary outcome was total abortion care costs. We used mixed-effects logistic regression adjusting for patient and abortion characteristics to examine the associations between distance traveled and subsequent abortion-related care at each location. RESULTS: Among all abortions (N=39,747), 3% (95% CI 2.9-3.3, n=1,232) were followed by an ED visit (3% first-trimester aspirations, 2% second trimester or later, and 4% medication abortions) and 25% (95% CI 24.1-24.9, n=9,745) were followed by a visit to the original abortion site (4% first-trimester aspirations, 3% second-trimester or later, and 77% medication abortions). Women traveling farther for their abortions had higher odds of visiting an ED (100 or more miles compared with less than 25 miles, first-trimester aspirations: adjusted odds ratio [OR] 2.29, 95% CI 1.50-3.49; medication abortions: adjusted OR 2.30, 95% CI 1.34-3.93) and lower odds of returning to their abortion site for follow-up (100 or more miles compared with less than 25 miles, first-trimester aspirations: adjusted OR 0.36, 95% CI 0.18-0.70; second trimester or later: adjusted OR 0.52, 95% CI 0.31-0.88; and medication abortions: adjusted OR 0.33, 95% CI 0.23-0.50). Costs were consistently higher when subsequent care occurred at an ED rather than the abortion site (median cost $941 compared with $536, P<.001). CONCLUSION: For most patients, greater distance traveled for abortion was associated with increased likelihood of seeking subsequent care at an ED. Increasing the number of rural Medicaid abortion providers and reimbursing providers for telemedicine and alternatives to routine follow-up would likely improve continuity of care and reduce state costs by shifting the location of follow-up from EDs back to abortion providers.

Analgesia/pain management in first trimester surgical abortion.

Management of pain during abortion is a critical aspect of patient care. Although it is not always possible to offer a range of pain control options in every setting, individualizing pain medications as much as possible for patients' preferences is likely to improve satisfaction with the abortion experience. Evidence suggests that higher volume (at least 200 mg lidocaine) and deeper injections are beneficial for cervical block. Adding intravenous sedation with a moderate dose of fentanyl and midazolam reduces the pain scores. Oral benzodiazepines may improve satisfaction and anxiety. Deep sedation and general anesthesia are important options for women with significant medical conditions or complicated procedures.

Misoprostol administered by epithelial routes: Drug absorption and uterine response.

OBJECTIVE: To quantify and compare serum levels and uterine effects following vaginal (dry), vaginal (moistened), buccal, and rectal misoprostol administration. METHODS: Forty women seeking elective abortion between 6 and 12 6/7 weeks were randomly assigned to receive 400 mug of misoprostol by one of four routes. A 2.5-mm pressure monitoring catheter was placed through the cervix to the uterine fundus to record uterine tone and activity during the 5-hour observation period. Serum levels of misoprostol acid were measured at 15 and 30 minutes, then every 30 minutes. RESULTS: The four groups were similar in age, race or ethnicity, body mass index, parity, and gestation. Serum levels after vaginal, vaginal moistened and buccal administration rose gradually, peaked between 15 and 120 minutes and fell slowly. Vaginal and vaginal moistened routes produced higher peak serum levels than buccal and rectal (445.9 and 427.1 compared with 264.8 and 202.2 pg/mL; P = .03) and higher serum concentration area under the curve at 5 hours (1,025.0 and 1279.4 compared with 519.6 and 312.5 pg-hr/mL; P < .001). Uterine tone and activity, however, were similar for buccal and the two vaginal routes. After rectal administration, serum levels peaked earlier (P < .001) then dropped more abruptly, and peak uterine tone (P < .001) and total activity (P = .04) were lower than after the other routes. CONCLUSION: Although serum levels were lower for buccal compared with the vaginal routes, the three routes produced similar uterine tone and activity. Rectal administration produced lower uterine tone and activity. Vaginal serum levels were two to three and a half times higher than those observed in prior misoprostol pharmacokinetic studies.

Misoprostol compared with laminaria before early second-trimester surgical abortion: a randomized trial.

OBJECTIVE: To compare the efficacy and acceptability of same-day misoprostol and overnight laminaria for cervical ripening before early second-trimester surgical abortion. METHODS: We performed a randomized, double-blinded, controlled trial comparing 400 microg of vaginal misoprostol, given 3-4 hours preoperatively, with overnight laminaria before early second-trimester surgical abortion among women at 13.0-16.0 weeks of gestation (n = 84). The primary outcome was procedure time, and the sample size was based on 95% power to detect a difference of 4.5 minutes between groups. Secondary outcomes included completion of the procedure on the first attempt, procedural difficulty, and patients' pain scores and preferences. RESULTS: The average gestational duration was 14 weeks 6 days. Procedures performed after laminaria were significantly faster than those after misoprostol (median 3.4 versus 7.2 minutes, respectively, P = .01). Laminaria patients had significantly greater dilation than misoprostol patients at abortion (mean 43 versus 33 French, P < .001), and more misoprostol patients required additional dilation (85% versus 21%, P < .001). Physicians rated 27% of the misoprostol procedures as moderate-markedly difficult versus 5% of laminaria procedures (P = .01). Differences in efficacy were pronounced among nulliparous patients. There were no significant differences in ability to complete the procedure on the first attempt or patients' intraoperative pain scores. More women in the misoprostol group would choose their assigned method again (93% versus 62%, P < .01), and 82% of all subjects preferred a 1-day procedure. CONCLUSION: Early second-trimester abortions take longer and are technically more challenging after cervical ripening with same-day misoprostol than with overnight laminaria, but patients prefer same-day misoprostol.

Misoprostol in gynecology.

Misoprostol is an important medication for gynecologic practice; however, it is not approved by the US Food and Drug Administration for any gynecologic indication. Evidence-based practice must guide our use of this important drug. Its use for medical abortion in conjunction with mifepristone or methotrexate is supported by a large body of high-quality evidence. There is also a rapidly growing amount of literature on the use of misoprostol for the management of miscarriage; however, more research is needed to optimize use. Solid evidence supports the efficacy of misoprostol for cervical ripening before first-trimester suction curettage abortion, and good evidence supports its use before hysteroscopy in premenopausal women; however, complications are rare with these procedures, making it difficult to assess any impact on complication rates. Most studies have not demonstrated a benefit for using misoprostol as a cervical ripening agent in postmenopausal women.

Prostaglandins for first-trimester termination.

Since the 1980s, when mifepristone combined with a prostaglandin was found to be safe and effective for early abortion, many studies have refined the regimens and investigated alternatives such as methotrexate plus misoprostol, and misoprostol alone. Evidence now demonstrates that more than 200 mg of mifepristone provides no additional benefit, that vaginal misoprostol is superior to oral, especially between 7 and 9 weeks' gestation, and that misoprostol may be safely self-administered at home. Buccal and sublingual routes of administration of misoprostol also are promising. Absolute contraindications to medical abortion arise infrequently. Gastrointestinal and other side-effects occur in about one-third of women, primarily after administration of the prostaglandin. Careful assessment before and after medical abortion is essential and can be accomplished in various ways, depending on the skills of the clinician.

A prospective randomized, double-blinded, placebo-controlled trial comparing mifepristone and vaginal misoprostol to vaginal misoprostol alone for elective termination of early pregnancy.

BACKGROUND: Vaginal misoprostol has been shown to be an effective single agent for medical abortion. This randomized, double-blinded, placebo-controlled trial compared a regimen of mifepristone and misoprostol with misoprostol alone for termination of early pregnancy. METHODS: 250 women with gestations < or = 56 days were randomized by a random number table to receive either 200 mg mifepristone orally or placebo followed 48 h later by 800 microg vaginal misoprostol. Administration of misoprostol was repeated every 24 h up to three doses if abortion failed to occur. Abortion success was defined as complete abortion without the use of surgical aspiration. RESULTS: Successful medical abortions occurred in 114 out of 119 subjects (95.7%) after mifepristone followed by vaginal misoprostol. In all, 110 out of 125 subjects (88.0%) successfully aborted after placebo and vaginal misoprostol. The higher success rate of complete abortion with the mifepristone and misoprostol regimen was statistically significant compared with the placebo and misoprostol regimen (P < 0.05). CONCLUSIONS: A regimen of mifepristone and misoprostol was significantly more effective for termination of pregnancies < or = 56 days than misoprostol alone. The 88% efficacy obtained with vaginal misoprostol alone may be clinically acceptable when mifepristone is not available.