RESUMEN
BACKGROUND: In Germany, oral emergency contraception (EC) with the active ingredients levonorgestrel (LNG) and ulipristal acetate (UPA) is available as over-the-counter (OTC) medicine only from community pharmacies (CPs). Because of the window of effect, which is limited to only a few days, CPs have a great responsibility to provide rapid and unimpeded access, while also ensuring "adequate" counseling. The aim was-for the first time in Europe and thus also in Germany for the methodology used in this study-to investigate immediate availability, pricing, and aspects of counseling. METHODS: Covert mystery calls were conducted in a random sample of CPs stratified by districts in the German capital Berlin. Each of the 263 CPs included was called once at random by one of two trained female student mystery callers. They simulated a product-based scenario for the UPA original ellaOne®, citing a contraceptive failure one day ago as the reason. RESULTS: Of 257 successfully called CPs, UPA preparations were immediately available in 98.4% (253/257) and LNG preparations in 86.8% (184/212) of CPs. Prices for UPA preparations varied from 15.95 to 42.95 (∆ 169%; median 35.00 [interquartile range (IQR) 5.91]) and for LNG preparations from 10.60 to 32.49 (Δ 207%; median 22.00 [IQR 5.76]). Information about the correct different window of effect of UPA and LNG preparations was provided in 69.8% (127/182) of CPs. UPA preparations were recommended in 63.1% (111/176) and LNG preparations in 17.2% (30/174) of CPs. Information was provided on how to take them as soon as possible in 30.8% (44/143) of CPs and on how to use them after vomiting in 46.0% (64/139). CONCLUSIONS: Berlin CPs support access through high immediate availability, especially to UPA preparations. However, access is hampered by high absolute price ranges of both UPA and LNG preparations, which could ideally be minimized by a comparison app. It is positive that CPs promote the benefits of UPA preparations by recommending them noticeably more often than LNG preparations. However, there are deficiencies in giving advice, so there is a need to raise awareness among pharmacy staff to ensure "adequate" counseling in advance over the phone.
RESUMEN
BACKGROUND: In Germany, there are two different active substances, levonorgestrel (LNG) and ulipristal acetate (UPA), available as emergency contraception (the "morning after pill") with UPA still effective even 72 to 120 h after unprotected sexual intercourse, unlike LNG. Emergency contraceptive pills have been available without a medical prescription since March 2015 but are still only dispensed by community pharmacies. The aim of this study was to determine the counselling and dispensing behaviour of pharmacy staff and the factors that may influence this behaviour in a scenario that intends that only the emergency contraceptive pill containing the active substance UPA is dispensed (appropriate outcome). METHODS: A cross-sectional study was carried out in the form of a covert simulated patient study in a random sample of community pharmacies stratified by location in the German state of Mecklenburg-Vorpommern and reported in accordance with the STROBE statement. Each pharmacy was visited once at random by one of four trained test buyers. They simulated a product-based request for an emergency contraceptive pill, stating contraceptive failure 3.5 days prior as the reason. The test scenario and the evaluation forms are based on the recommended actions, including the checklist from the Federal Chamber of Pharmacies. RESULTS: All 199 planned pharmacy visits were carried out. The appropriate outcome (dispensing of UPA) was achieved in 78.9% of the test purchases (157/199). A significant correlation was identified between the use of the counselling room and the use of a checklist (p < 0.001). The use of a checklist led to a significantly higher questioning score (p < 0.001). In a multivariate binary logistic regression analysis, a higher questioning score (adjusted odds ratio [AOR] = 1.41; 95% CI = 1.22-1.63; p < 0.001) and a time between 12:01 and 4:00 p.m. (AOR = 2.54; 95% CI = 1.13-5.73; p = 0.024) compared to 8:00 to 12:00 a.m. were significantly associated with achieving the appropriate outcome. CONCLUSIONS: In a little over one-fifth of all test purchases, the required dispensing of UPA did not occur. The use of a counselling room and a checklist, the use of a checklist and the questioning score as well as the questioning score and achieving the appropriate outcome are all significantly correlated. A target regulation for the use of a counselling room, an explicit guideline recommendation about the use of a checklist, an obligation for keeping UPA in stock and appropriate mandatory continuing education programmes should be considered.