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.

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.

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.

A study of the capability of manufacturers of generic hormonal contraceptives in lower- and middle-income countries.

PURPOSE: Studies were undertaken to assess the capability, competence and capacity of manufacturers of oral and injectable hormonal contraceptives in lower- and middle-income countries. METHODS: A qualitative study on 41 companies, which comprised in-depth interviews and facility observations, was undertaken. Also an in-depth quantitative study of 14 companies was undertaken, of which 3 have not been included in the first study. Following review of a questionnaire and other documentation, a visit was undertaken to each factory to assess staff competence, manufacturing facilities, manufacturing processes, quality management, worker safety and environmental protection. RESULTS: Of the 44 companies from 15 countries, less than 30% would meet the current Good Manufacturing Practice requirements of the World Health Organization (WHO), the Pharmaceutical Inspection Cooperation Scheme or any stringent regulatory authority; a further 20% could comply with investment and improvements in quality management. Few companies are able to develop adequate registration dossiers. CONCLUSION: There is a limited number of companies that are capable of manufacturing high-quality generic products and which can provide a complete registration dossier for use outside their home markets. It is essential that, in the future, procurement agencies only use suppliers that are prequalified by WHO for the procurement of hormonal contraceptives.

Modelling costs and outcomes of expanded availability of emergency contraceptive use in British Columbia.

BACKGROUND: Emergency contraception (EC) can potentially reduce unwanted pregnancies and abortions. However, these agents are underused due to lack of awareness and barriers to utilization. While earlier economic evaluations have indicated that use of EC is potentially cost-effective, recent evidence of a lower risk of pregnancy following unprotected intercourse than previously reported suggest prior studies may have over-estimated cost savings. OBJECTIVES: To model cost savings and pregnancy-related outcomes associated with the policy change authorizing pharmacist provision of EC in British Columbia, and to estimate the costs of initiatives to further women's awareness and utilization of EC that would result. METHODS: Three decision analytic models were developed evaluating current EC utilization (physician-only), EC utilization following pharmacist provision and potential expanded EC awareness and utilization following a public awareness initiative. Models were developed from the Ministry of Health perspective for 2001 using cost and event data from the Ministry supplemented by data from the literature. RESULTS: Current EC utilization saved the Ministry $2.20 million (95% CR: $0.15 million, $4.90 million) in medical costs the first year, and incremental savings from pharmacist provision was $0.64 million (95% CR: $0.24 million, $1.28 million). A public awareness initiative costing less than $2.57 million (95% CR: $0.22 million, $5.75 million) annually is potentially cost saving. CONCLUSIONS: Pharmacist provision of EC was cost saving to the Ministry, even when the estimated risk of pregnancy in the population is less than assumed in previous studies. Increasing EC availability directly from pharmacists and increasing EC awareness have the potential to reduce health care costs.

Hospital religious affiliation and emergency contraceptive prescribing practices.

With access to reproductive health care eroding, examination of prescribing of contraception, including emergency contraception (EC), is important. We examined whether working in a family practice affiliated with a religious institution changes the likelihood of a provider prescribing EC. Our survey asked about EC prescribing practices in a range of situations. As predicted, practitioners in non-religiously affiliated practices reported higher rates of prescribing EC than those in religiously affiliated practices. In both cases, however, the practitioners' prescribing patterns were inadequate.

Norplant insertions at the Zeynep Kamil Gynecologic and Pediatric Training Research Hospital in Istanbul.

OBJECTIVE: This study was conducted to determine sociodemographic characteristics and usage interval according to insertion period, observed side effects and reasons for discontinuation in 756 cases where Norplant was inserted and removed for any reasons at our hospital since 1994. METHODS: Seven-hundred and fifty-six cases in whom Norplant was inserted and removed since 1994 were included in our study. Sociodemographic characteristics, former contraception method, reasons for choosing this method and side effects seen during the usage period were determined. In all cases, reasons for discontinuation, sociodemographic characteristics and usage interval according to the insertion period were investigated. Statistical analysis of this study was performed with SPSS 9.0 (analysis of variance). RESULTS: Mean age of cases was 26.5 +/- 4.9 years, mean number of living children was 2.0 +/- 1.2, and 50.4% of cases had no health insurance. Most of the cases used coitus interruptus previously as a contraceptive method and chose Norplant use because of its effectiveness. Insertion periods were as follows: interval, n = 513 (67.9%); postpartum, n = 127 (16.8%) and postabortion, n = 116 (15.3%). Various side effects were detected in 79.8% of the cases. Bleeding problems were seen in 69.8%. Pregnancy occurred in only one case. Mean Norplant usage interval was 3.08 +/- 1.68 years. The longer usage interval was seen in cases with lower educational level. When we compared the usage intervals between interval, postpartum and postabortion periods, we found that the interval group had a shorter mean duration of Norplant use. Discontinuation because of bleeding problems occurred in 38.1%. Removal of all Norplant implants was performed at a single session in 731 cases (96.4%). After Norplant removal, most cases selected either condom or IUD as the contraceptive method. CONCLUSION: It is concluded that despite the frequent occurrence of side effects, Norplant is a modern, long-acting, highly effective, reversible, easy-to-use, satisfactory form of birth control, especially in selected cases.

Emergency contraception: lessons learned from the UK.

CONTEXT: Since January 2001, women aged over 16 years in the UK have been able to purchase progestogen-only emergency hormonal contraception from pharmacists without prescription. This paper outlines the context in which these changes took place, including contraceptive choices in the UK, changes within the pharmacy profession and political pressures. OBSERVATIONS: We chart the multisectoral developments required to make emergency contraception (EC) available without prescription in the UK, from clinical research findings and results on the views and behaviour of health care professionals and users of EC, through to professional and policy developments, including challenges during and after this process. DISCUSSION: Lessons learnt from the innovative experience of the deregulation of EC in the UK apply to other regions currently considering similar change. We extrapolate internationally applicable lessons including the importance of stakeholder partnership, transparency and cautious pace of change, and the vital role of professional groups. CONCLUSION: Although this change brought a new element of reproductive choice to some women, significant barriers to access to EC still remain for young women and women unable to afford the high price ( 24/euro;37/$39) of pharmacy purchase in the UK.