The Quality of Counselling for Oral Emergency Contraceptive Pills—A Simulated Patient Study in German Community Pharmacies

Abstract

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.

A Nationwide Mystery Caller Evaluation of Oral Emergency Contraception Practices from German Community Pharmacies: An Observational Study Protocol

“…It will be interesting to see to what extent information gathering or a possible recommendation of oral EC takes place on the phone or is referred to a visit to the CP. In any case, the only national SPM study on oral EC to date has identified deficits in the provision of self-medication consultations with the help of visits in the CPs studied [60]. Regarding the availability of oral EC, international SPM studies [37][38][39]41,42,45] suggest that there are problems-especially with UPA.…”

“…The planned study is to be based on a cross-sectional design, conducted with the help of the SPM in the form of covert mystery calls and reported in accordance with the 'STROBE Statement-Checklist of items that should be included in reports of cross-sectional studies' [62]. Against the background of a nationwide study, calls are to be preferred to visits-which have already been used in German CPs [15,60,63,64], but only in relation to one city or one federal state-as the implementation of calls without the requirement of a physical presence in the CP is less costly and thus more feasible. Following the international literature [59,[65][66][67], the SPM in the form of covert mystery calls is a covert participant observation by a person (mystery caller (MC)), -who contacts a CP, -with the help of a call, -to simulate a lifelike conversation situation based on a predefined scenario.…”

“…To avoid the problems described above, the simulated patient methodology (SPM) is recommended [55,56] in the international literature as the "gold standard" [57]-also taking into account the relatively high administrative and financial effort as well as comparatively small sample sizes [57] and any intra-and inter-observer variabilities [58]-with which a lifelike conversational situation can be depicted [59]. However, only one SPM study on oral EC is known for Germany [60], which investigated the provision of self-medication consultations for oral EC, but neither availability nor pricing, and is also a representative analysis for only one federal state. Therefore, it would be appropriate to conduct a representative nationwide study with the following objectives: This study is planned on the basis of the present protocol.…”

A systematic review of the use of simulated client method in examining medicine price

“…For the purposes of this study, the simulated patient (SP) method has been selected as the primary term. This method, which rst started as a means of classroom appraisal [2], is now widely applicable in various healthcare related elds, including medicine, nursing, pharmacy, and dentistry [3][4][5][6]. It generally involves an individual role-playing as a patient or customer.…”

The Relegated Goal of Health Institutions: Sexual and Reproductive Health

“…This is displayed in this issue by Langer et al in a study carried out in pharmacies in Germany. [ 9 ]. In the case of having to perform an abortion due to an unwanted pregnancy or for any other reason, it must be carried out in safe conditions for the woman, and therefore it is necessary to implement training and awareness programs [ 10 ].…”