Increases in retail sales of over-the-counter levonorgestrel emergency contraception in the United States, 2016-2022.

OBJECTIVES: To understand patterns in demand for emergency contraception (EC), we characterize the sales of over-the-counter (OTC) levonorgestrel (LNG) EC in the United States from traditional retail outlets. STUDY DESIGN: We describe sales of OTC LNG EC using retail sales data aggregated from traditional retail channels, including grocery stores, drug stores, mass merchandisers, club stores, dollar stores, and military outlets. RESULTS: Sales of OTC LNG EC doubled between 2016 and 2022 (approximately 7.2-14.8 million). CONCLUSIONS: Increasing sales of EC are consistent with increased use and use frequency of EC by those at risk of pregnancy in the United States. IMPLICATIONS: OTC LNG EC sales since 2016 exceed what national survey usage estimates would suggest, indicating that national surveys underreport EC use, those using EC purchase it somewhat frequently, and/or individuals stockpile EC for later use. The role of EC in individual contraceptive strategies, particularly as access to reproductive healthcare is restricted, warrants further study.

Availability of ulipristal acetate: A secret shopper survey of pharmacies in a metropolitan area on emergency contraception.

OBJECTIVES: To assess levonorgestrel (LNG) and ulipristal acetate (UPA) availability in pharmacies in a metropolitan area. METHODS: A cross-sectional survey was conducted of all identified pharmacies within 25 miles of an urban medical center in Kansas City, KS. We categorized the pharmacies as dedicated commercial (national chains), store-associated (affiliated with a general merchandise or grocery store), or independent. We assessed LNG and UPA availability or time to availability if not currently stocked. RESULTS: We contacted 165 pharmacies. Of the 165 pharmacies, few stocked UPA (12/165, 7%) whereas the majority stocked oral LNG (128/165, 78%). Dedicated commercial pharmacies were more likely to carry UPA than store-associated and independent pharmacies (11/84 [13%] vs. 1/61 [1%] vs. 0/20, respectively; P = 0.016). Most pharmacies that did not stock UPA reported that they could obtain it within 24 hours (94/153, 62%). Dedicated commercial pharmacies were most likely report the ability to obtain UPA in 24 hours (P = 0.016). CONCLUSION: Few pharmacies stock UPA, the most effective form of oral emergency contraception. Enhanced communication between medical providers and pharmacists within current laws and regulations could enhance patient access to UPA.

Evaluating Community Pharmacy Responses About Levonorgestrel Emergency Contraception by Mystery Caller Characteristics.

PURPOSE: Since restrictions on nonprescription sales were removed in 2013, levonorgestrel emergency contraception (EC) should be available without a prescription at pharmacies for consumers of all genders and ages. Using mystery callers, we assessed variations in availability of and access to EC. METHODS: In 2015-2016, three sets of mystery callers (two female physicians, two adolescent females, and two adolescent males) each called all licensed retail pharmacies in five U.S. cities using standardized call scripts. Scripts assessed same-day availability and subsequent access to EC for 17-year-olds. Data on various characteristics of calls were collected and compared by caller type. RESULTS: Among the 993 pharmacies called, same-day availability for EC was approximately 80%, with no differences by caller types (p = .34). However, 10.7% of calls made by the adolescent male caller and 8.3% made by the adolescent female caller resulted in incorrectly being told they could not obtain EC based on age, compared to only 1.6% of calls made by the physician (p < .01). Pharmacy staff stated correctly that EC was available over-the-counter more often to adolescent male callers (62.0%) than adolescent females (51.6%) or female physicians (57%) (p < .01). Physicians were more likely to be placed on hold, talk to a pharmacist, or be transferred to a pharmacist (p < .01) than adolescents. CONCLUSIONS: Persistent barriers to accessing EC exist for adolescents despite regulatory changes to make EC available over-the-counter, especially for females. Additional work to remove these barriers is needed to assure timely access for those who require effective pregnancy prevention.

Single-Dose Levonorgestrel Emergency Contraception and Silent Barriers to Its Access: Is It Really Just One Step?

BACKGROUND: Single-dose levonorgestrel has been legally available over the counter in the United States without age restriction since 2013. The objective of this study was to discover if there are barriers to access and to determine if such barriers vary based on the gender of the person making the purchase. MATERIALS AND METHODS: A male and female caller contacted 146 Richmond, Virginia pharmacies listed on the Plan B One Step® website. Ultimately, these callers interviewed 90 pharmacies via phone and used a rehearsed standardized script to ask eight questions regarding emergency contraception (EC) in relation to availability, age restrictions, parental consent, counseling requirements, and a male's ability to purchase the product. The statistical data were analyzed using Fisher's exact test. RESULTS: Pharmacy employees provided incorrect information to both men and women regarding age restrictions for purchasing Plan B One Step 51% of the time. However, only seven of the pharmacy employees counseled that males were unable to purchase the medication. Both callers received correct information regarding parental consent and in-store counseling at the time of purchase. Pharmacy technicians provided the majority of information, and the male caller was more likely to be transferred to another person when requesting the medication (9 vs. 0 transfers for the male and female callers, respectively). CONCLUSION: Given the inconsistent data provided to the public regarding the purchase of EC, clinicians are obligated to convey accurate up-to-date information to patients about emergency contraceptive products as part of their counseling and should not assume that consumers receive accurate information when inquiring about over-the-counter EC.

Barriers to Single-Dose Levonorgestrel-Only Emergency Contraception Access in Retail Pharmacies.

OBJECTIVES: In February 2014, the Food and Drug Administration updated its regulations to make all single-dose levonorgestrel-only emergency contraception (LNG-EC) available over the counter. This study examines the availability and access to LNG-EC shortly after this policy change, and any additional barriers to obtaining LNG-EC in Colorado retail pharmacies. STUDY DESIGN: From June to July 2014, three female interviewers posing as women seeking LNG-EC conducted a telephone survey of all 633 Colorado retail pharmacies listed in The Little Blue Book (2014) phone directory. Completely accessible was defined as LNG-EC available on store shelves for purchase without presentation of an ID or prescription on the day of the call. RESULTS: Of 633 pharmacies analyzed, 85.0% (538/633) were in urban settings and 85.3% (540/633) were chain stores. Eighteen of 64 (28.1%) counties in Colorado did not have a pharmacy listed in the phone directory. Overall, 86.9% of pharmacies (550/633) had EC in stock on the day of contact but only 23.2% (147/633) of these had EC completely accessible. Of pharmacies with EC in stock, 41.6% (229/550) kept it behind the counter and 56.0% (308/550) required additional documentation to purchase. In stock and completely accessible rates were not different across rural, urban, and frontier geographic regions within the state (p = .066 and p = .905, respectively), but were significantly different across independent, chain, and 24-hour type stores (p < .001 and p = .008, respectively). In stock rates were 57.5% (42/73), 90.4% (488/540), and 100% (20/20) for independent, chain, and 24-hour stores respectively. CONCLUSIONS: Rates of completely accessible LNG-EC are low in Colorado despite high rates of availability. Behind-the-counter status and proof-of-age requirements are identified as the main sources of access restriction in Colorado.

Emergency Contraception.

Emergency contraception (EC) may help prevent pregnancy in various circumstances, such as contraceptive method failure, unprotected sexual intercourse, or sexual assault, yet it remains underused. There are 4 approved EC options in the United States. Although ulipristal acetate requires a provider's prescription, oral levonorgestrel (LNG) is available over the counter for women of all ages. The most effective method of EC is the copper intrauterine device, which can be left in place for up to 10 years for efficacious, cost-effective, hormone-free, and convenient long-term primary contraception. Ulipristal acetate tends to be more efficacious in pregnancy prevention than is LNG, especially when taken later than 72 hours postcoitus. The mechanism of action of oral EC is delay of ovulation, and current evidence reveals that it is ineffective postovulation. Women who weigh more than 75 kg or have a body mass index greater than 25 kg/m(2) may have a higher risk of unintended pregnancy when using oral LNG EC; therefore, ulipristal acetate or copper intrauterine devices are preferable in this setting. Providers are often unaware of the range of EC options or are unsure of how to counsel patients regarding the access and use of EC. This article critically reviews current EC literature, summarizes recommendations, and provides guidance for counseling women about EC. Useful tips for health care providers are provided, with a focus on special populations, including breast-feeding women and those transitioning to long-term contraception after EC use. When treating women of reproductive age, clinicians should be prepared to counsel them about EC options, provide EC appropriately, and, if needed, refer for EC in a timely manner.

Status of Emergency Contraceptives in Europe One Year after the European Medicines Agency's Recommendation to Switch Ulipristal Acetate to Non-Prescription Status.

BACKGROUND: In November 2014, the European Medicines Agency (EMA) recommended switching the emergency contraceptive (EMC) ulipristal acetate to non-prescription status. This study's objective is to assess the current legal status of the two EMCs ulipristal acetate and levonorgestrel in Europe and to report on the development of sales figures for EMCs since they were made freely available. METHODS: Health authorities were contacted in autumn 2015 and asked about the current status of EMCs and whether the sales figures had changed after a switch to non-prescription status. Additionally, data on consumption were collected in 18 German community pharmacies. RESULTS: As of November 2015, most countries in the European Union (EU) have followed the EMA recommendation. Hungary kept the prescription-only status. In Malta, EMC drugs are not authorized. Germany and Croatia switched levonorgestrel to non-prescription status as well. Of the EU candidate and European Free Trade Association countries, ulipristal acetate is available without prescription in Norway and Bosnia and Herzegovina only. Several countries reported an increase in EMC sales since the switch. CONCLUSIONS: An EMA recommendation can strongly contribute to the harmonization of a drug's legal status in the EU. In most European countries, ulipristal acetate and/or levonorgestrel are now freely available.

Pharmacy access to ulipristal acetate in Hawaii: is a prescription enough?

OBJECTIVE: To determine pharmacy availability of ulipristal acetate (UPA) and compare to availability of levonorgestrel-containing emergency contraceptive pills (LNG-ECPs). METHODS: We conducted an observational population-based study utilizing a telephone-based secret shopper methodology. Researchers called all 198 unique retail pharmacies in Hawaii on December 2013-June 2014, representing themselves as patients and physicians. RESULTS: Only 2.6% of pharmacies had UPA immediately available, though 22.8% reported ability to order UPA. In contrast, 82.4% reported immediate availability of LNG-ECPs. No significant difference in availability was reported to patients and physicians. CONCLUSIONS: Availability of UPA is limited and significantly lower compared to LNG-ECPs. The study period did overlap with a change in distributor for UPA, likely capturing some disruption of the supply chain. IMPLICATIONS: Systems-based interventions are needed to address barriers to obtaining UPA.

Male access to emergency contraception in pharmacies: a mystery shopper survey.

BACKGROUND: Pharmacy access to emergency contraception (EC) could involve men in pregnancy prevention. The objectives were to assess the availability and cost of EC. STUDY DESIGN: Male mystery shoppers visited 158 pharmacies in three neighborhoods in New York City. They asked for EC and its cost and noted weekend hours. RESULTS: Twenty-two (73.3%) of 30 pharmacies created barriers to get EC. The cost of EC was higher in the higher-socioeconomic status (SES) neighborhood (p<.001), and the higher-SES neighborhood pharmacies had a greater number of weekend hours (p<.001). CONCLUSIONS: Overall, males had a 20% probability of not being able to access EC. The national dialogue should include males.

Use of simulated patients to evaluate combined oral contraceptive dispensing practices of community pharmacists.

BACKGROUND: Combined oral contraceptive (COC) use is the most commonly used reversible method of birth control. The incorrect use of COCs is frequent and one of the most common causes of unintended pregnancies. Community pharmacists (CPs) are in a strategic position to improve COC use because they are the last health professional to interact with patients before drug use. OBJECTIVE: To evaluate the COC dispensing practices of CPs in a developing country. METHOD: A cross-sectional study was conducted in community pharmacies of Assis and Ourinhos microregions, Brazil, between June 1, 2012, and October 30, 2012. Four simulated patients (SPs) (with counseled audio recording) visited community pharmacies with a prescription for Ciclo 21(®) (a COC containing ethinyl estradiol 30 mcg + levonorgestrel 15 mcg). The audio recording of every SP visit was listened to independently by 3 researchers to evaluate the COC dispensing practice. The percentage of CPs who performed a screening for safe use of COCs (i.e., taking of patients' medical and family history, and measuring of blood pressure) and provided counseling, as well as the quality of the screening and counseling, were evaluated. RESULTS: Of the 185 CPs contacted, 41 (22.2%) agreed to participate in the study and finished the study protocol. Only 3 CPs asked the SP a question (1 question asked by each professional), and all of the questions were closed-ended, viz., "do you smoke?" (n = 2) and "what is your age?" (n = 1). None of the CPs measured the patient's blood pressure. Six CPs provided counseling when dispensing COCs (drug dosing, 5 CPs; possible adverse effects, 2 CPs), and one CP provided counseling regarding both aspects. CONCLUSION: The CPs evaluated did not dispense COC appropriately and could influence in the occurrence of negatives therapeutic outcomes such as adverse effects and treatment failure.

Access to levonorgestrel emergency contraception: science versus federal politics.

Past US FDA decisions about emergency contraception (EC) have been subject to undue political influence, and last year's barring of over-the-counter access to Plan B One-Step(®) for those under the age of 17 years is no exception. The US Department of Health and Human Services cited insufficient data on EC use for females aged 11-12 years. These youngest adolescents, however, rarely need EC: data from California (USA) show that in 2009, fewer than one in 10,000 females under the age of 13 years received EC. Maintaining barriers to safe and effective EC is not medically necessary and conflicts with national goals to decrease teenage and unintended pregnancies.

Emergency contraception: separating fact from fiction.

Rates of unintended pregnancy and abortion are high, yet many doctors do not feel comfortable discussing emergency contraception with patients, even in cases of sexual assault. Since the approval of ulipristal acetate (ella) for emergency contraception, there has been even more confusion and controversy. This article reviews various emergency contraceptive options, their efficacy, and special considerations for use, and will attempt to clarify myths surrounding this topic.

Increasing access to emergency contraception through online prescription requests.

OBJECTIVE: To describe a pilot program, Plan B Online Prescription Access, to provide easy access to prescriptions for emergency contraception via the Internet. STUDY DESIGN: We measured electronic prescriptions for Plan B (Duramed Pharmaceuticals, Cincinnati, Ohio) by month over time. Pharmacists faxed patient-generated prescriptions back to the Department of Public Health for confirmation. RESULTS: Despite no marketing, within the first 18 months of the program, 152 electronic prescriptions for Plan B were requested by 128 female San Francisco residents. Seventy-eight prescriptions were filled (51%) by pharmacists. CONCLUSION: If correctly marketed, online prescriptions for Plan B have the potential to be an effective means of increasing emergency contraception access in both urban and rural settings across the United States. Further user-acceptability studies are warranted.

Experience with Norplant at a Nigerian teaching hospital.

OBJECTIVES: To determine the acceptance of Norplant implants while it was in use and share our experience with other Norplant providers. DESIGN: Retrospective descriptive study. SETTING: The family planning clinic of the Jos University Teaching Hospital, Jos, Nigeria. RESULTS: During the 21-year period, January 1985 to December 2005, a total of eighteen thousand, two hundred and ninety one (18,291) new clients accepted various modern contraceptive methods in the family planning clinic of Jos University Teaching Hospital, Nigeria. Norplant was accepted by 1,333 clients (4.9%) as against the intrauterine devices (IUDs) 25.4%, and Oral Contraceptive Pills (OCP) 22.9%. Female sterilisation was a contraceptive method of choice in 21.2%, the injectables in 13.9%, and the male condom in 9.3%. Failure rate was 0.37% and continuity rate was high among users. The Norplant contraceptive implant was accepted by women of mean age of 29.6 years and women of all parity. The acceptance pattern demonstrated a multi-nodal pattern from the time of introduction in 1985 to December 2005 when supply came to an abrupt stop. The greatest barriers to Norplant use were non- availability and high cost of the commodity. CONCLUSION: Norplantimplants provided contraceptive protection with high reliability, safety, independence from user compliance, rapid return of pre-existing fertility after removal, good tolerability, and relatively simple and quick insertion and removal. The capsules will definitely be used as a reference for similar contraceptive products in the contraceptive market.