---
title: "Community pharmacy telephone counseling often leads to unnecessary oral emergency contraception re"
id: "plos-one-20-do-community-pharmacies-unnecessarily-recommend-oral-emergency-contraception-a"
canonical_url: "https://medichelpline.com/clinical-feed/plos-one-20-do-community-pharmacies-unnecessarily-recommend-oral-emergency-contraception-a"
content_type: "clinical_feed_article"
specialty: "Pharmacology"
source_name: "PLOS ONE (Medicine)"
source_url: "https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0361027"
published_at: "2026-10-23T14:00:00.000Z"
evidence_level: "Journal Feed"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Community pharmacy telephone counseling often leads to unnecessary oral emergency contraception re
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/plos-one-20-do-community-pharmacies-unnecessarily-recommend-oral-emergency-contraception-a
- **Specialty:** [Pharmacology](https://medichelpline.com/clinical-feed/pharmacology.md)
- **Primary Source:** PLOS ONE (Medicine)
- **Source URL:** [Original Journal Publication](https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0361027)
- **Published At:** 2026-10-23T14:00:00.000Z
- **Evidence Rating:** Journal Feed
## Executive GIST (TL;DR)
- A nationwide mystery caller study assessed telephone counseling on **oral emergency contraception (EC)** in 376 German community pharmacies using a stratified random sample. Trained female callers simulated a single missed combined oral contraceptive pill within a 12-hour window, a scenario in which EC is not indicated per the **BAK guideline**. - Calls were monitored by a second observer to ensure data quality; 322 calls were included in the primary analysis after exclusions. The study used the BAK checklist questions to score information gathering (maximum 4 points). - An appropriate counseling outcome (no EC recommended) occurred in 44.4% (143/322) of calls; oral EC was unnecessarily recommended in 49.1% (158/322). The median questioning score was 2.0 out of 4.0 points. - Multivariable logistic regression identified a higher questioning score and the identity of the mystery caller as significantly associated with an appropriate outcome. The source reported qualitative observations of both adequate and deficient counseling practices. - Authors argued that deficits in information gathering and recommendations warrant explicit guidance to use the BAK checklist for telephone consultations and targeted training for pharmacy staff. - The study noted an unexpected association between certain mystery callers and better outcomes, and recommended research into whether vocal characteristics or names influence telephone counseling decisions. - The source did not report specific training content, exact checklist question wording, or detailed demographic data for pharmacy staff involved in calls.
## Clinical Analysis & Structured Key Points
Do community pharmacies unnecessarily recommend oral emergency contraception? A nationwide mystery caller investigation in Germany | PLOS One Browse Subject Areas ? Click through the PLOS taxonomy to find articles in your field. For more information about PLOS Subject Areas, click here . Article Authors Metrics Comments Media Coverage Peer Review Reader Comments Figures Figures Abstract Background Since 2015, oral emergency contraceptives (ECs) have been available in German community pharmacies without prescription as over-the-counter medicines. Given the financial burden, unnecessary hormonal exposure and associated side effects, systematic information gathering is crucial to prevent unnecessary recommendations. This study aimed to determine whether pharmacy staff ask the checklist questions recommended by the German Federal Chamber of Pharmacists (BAK) guideline and provide correct recommendations when oral EC is not indicated (appropriate outcome), and to examine associated factors. Methods A nationwide study using the simulated patient methodology – considered the “gold standard” – was conducted with a stratified random sample of 376 community pharmacies across Germany. Eight trained female mystery callers aged 21–24 simulated a scenario in which a combined oral contraceptive was forgotten once after sexual intercourse. However, the pill could still be taken within the 12-hour window, making oral EC unnecessary according to the BAK guideline. To ensure quality, each call was monitored by a second observer. Results Of 376 mystery calls conducted, 322 were included in the primary analysis. An appropriate outcome was achieved in 44.4% (143/322), while oral EC was unnecessarily recommended in 49.1% (158/322). The median questioning score was 2.0 of 4.0 points. A multivariable logistic regression model showed that a higher questioning score and mystery caller identity were significantly associated with the appropriate outcome. Qualitative findings indicated both positive counseling practices and notable deficiencies among pharmacy staff. Conclusion The results show deficits in information gathering and appropriate recommendations. To improve counseling, the consistent use of the BAK checklist during telephone consultations should be explicitly recommended in the relevant guideline. Targeted training for pharmacy staff may help address professional and communication deficits. Surprisingly, some mystery callers were significantly associated with the appropriate outcome, highlighting the need for further research on the influence of vocal characteristics and last names in telephone consultations. Citation: Langer B, Beck A, Dreier AM, Gabrieljan R, Hilgenhof H, Latuske J, et al. (2026) Do community pharmacies unnecessarily recommend oral emergency contraception? A nationwide mystery caller investigation in Germany. PLoS One 21(10): e0361027. https://doi.org/10.1371/journal.pone.0361027 Editor: Arupendra Mozumdar, Connexi, INDIA Received: May 7, 2026; Accepted: October 2, 2026; Published: October 23, 2026 Copyright: © 2026 Langer et al. This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. Data Availability: All relevant data are within the paper. Funding: The author(s) received no specific funding for this work. Competing interests: The authors have declared that no competing interests exist. Introduction Globally, an estimated 48.0% of all pregnancies are unintended [ 1 ]. In Germany, the corresponding proportion is lower, at 37.0% [ 2 ]. Although this proportion is approximately eleven percentage points below the international average, unintended pregnancies remain a substantial burden for affected women, with the potential for serious physical, emotional, and social consequences [ 3 – 5 ]. To prevent pregnancy after unprotected sexual intercourse (UPSI), the World Health Organization recommends the use of emergency contraception (EC) [ 6 ]. In Germany, the most widely known form of EC is oral EC [ 7 ]. Two oral EC preparations are available, containing either the active ingredients levonorgestrel (LNG) or ulipristal acetate (UPA) [ 8 ]. LNG is effective for up to 72 hours after UPSI, whereas UPA has a longer window of effectiveness of up to 120 hours and is considered more effective overall [ 9 , 10 ]. Irrespective of the preparation, effectiveness increases the sooner oral EC is taken after UPSI [ 6 ]. To ensure rapid access, oral ECs have been available in Germany without prescription as over-the-counter (OTC) medicines since 2015 [ 11 ], although dispensing is restricted to community pharmacies (CPs) [ 12 ]. In 2024, 96.6% of the 895,000 packages sold were dispensed OTC [ 13 ], and sales volume has increased by 85.2% since 2015 [ 14 ]. This increase reflects improved access following the switch to OTC status, accompanied by a marked shift from prescription-based dispensing to self-medication [ 14 ]. Although pharmacy and OTC access may facilitate more timely use of oral EC, available evidence has not demonstrated a clear reduction in unintended pregnancy compared with prescription-only access [ 15 ]. This development underscores the increasingly important role of CPs in access to and counseling on oral EC. In Germany, counseling may be provided not only by pharmacists but also by non-pharmacists, such as pharmaceutical engineers and pharmaceutical technical assistants, if authorized by the pharmacy manager [ 16 ]. German pharmacists are legally required to provide “adequate” counseling [ 16 ]. To support this, the German Federal Chamber of Pharmacists (BAK) published a guideline, most recently updated in 2021 [ 17 ]. This guideline recommends “personal” counseling and includes a checklist intended to ensure that relevant information is obtained prior to a recommendation. However, the term “personal” counseling remains insufficiently defined, particularly with regard to whether it includes telephone consultations. This lack of clarity is especially relevant given the increasing use of telephone-based counseling in CP practice [ 18 ]. The checklist questions are designed to collect the relevant information needed to determine whether oral EC is indicated and were therefore used to assess information gathering during counseling, but not to determine the appropriateness of the recommendation itself. However, the use of the checklist is neither mandatory nor explicitly recommended in the guideline. Importantly, the guideline also provides clear recommendations for cases of missed intake of a combined oral contraceptive: if the pill is taken less than 12 hours late, oral EC is not required [ 17 ]. An unnecessary recommendation and subsequent purchase of oral EC as an OTC medicine may impose a financial burden on the women concerned [ 19 , 20 ]. This is because the cost of oral EC is relatively high [ 21 , 22 ] compared to other OTC medicines, especially for minor ailments [ 23 – 26 ]. Furthermore, in Germany, statutory health insurance only reimburses the cost (minus a copayment) for women up to their 22nd birthday and only if a prescription is issued [ 27 ]. Possible financial consequences may be accompanied by unnecessary hormonal exposure and associated side effects for affected women. Common side effects occurred at similar frequencies with UPA and LNG. In a randomized trial, headache was reported by 19.3% and 18.9%, dysmenorrhoea by 12.9% and 14.3%, nausea by 12.8% and 11.3%, and abdominal pain by 5.1% and 6.7% of women receiving UPA and LNG, respectively [ 28 ]. Furthermore, the use of oral EC can be associated with shame, stigma, and fear of judgment for the women affected [ 29 – 31 ]. These financial, physical, and psychosocial implications underscore the importance of “adequate” counseling. Nevertheless, consistent with findings from international studies [ 32 – 40 ], counseling deficits regarding oral ECs have also been identified in German CPs [ 41 – 43 ]. Importantly, the latter studies did not examine questions relating to correct recommendations. In another German study, however, pharmacists surveyed stated that in cases of questionable need (e.g., when combined oral contraceptives were taken less than 12 hours late), they still dispensed oral ECs in almost half of all cases [ 44 ]. Given that this was a self-reported survey and therefore susceptible to social desirability bias [ 45 ], the true prevalence is likely underestimated [ 46 , 47 ]. The simulated patient methodology (SPM), implemented either through covert on-site visits or via covert mystery callers (MCs), helps to avoid these disadvantages [ 45 ]. Two SPM visit studies conducted in Australia showed that pharmacists frequently provided unnecessary recommendations and dispensed oral EC [ 48 , 49 ]. To date, the only SPM visit study on oral EC in Germany examined the converse scenario, in which UPA dispensing was indicated, and reported incorrect recommendations [ 50 ]. The first MC study on oral EC conducted in Europe – and therefore also in Germany – identified certain counseling problems [ 21 ], but did not address unnecessary recommendations. These documented counseling deficits, along with possible commercial incentives [ 51 ], suggest that oral ECs may be recommended (and sold) unnecessarily. To our knowledge, no prior MC study worldwide has explicitly quantified the extent of unnecessary oral EC recommendations. Using an MC approach, this study therefore aimed to investigate whether pharmacy staff ask the questions included in the BAK checklist and make appropriate recommendations in a scenario in which oral EC is not indicated (appropriate outcome, AO). Secondarily, we aimed to assess the influence of independent variables on the AO. Materials and methods Study design This cross-sectional study was based on the internationally established SPM in the CP setting [ 52 , 53 ]. Mystery calls were used as the specific form of SPM [ 18 , 54 , 55 ]. In this context, MCs contacted a CP by telephone as covert participant observers. Based on a predefined scenario, the MCs simulated a realistic conversation. Each call was subsequently evaluated using a standardized assessment form containing predefined items, enabling the identification of potential quality deficits [ 56 ]. Reporting of this study followed the STROBE statement for cross-sectional studies [ 57 ]. In addition, the simulation research guidelines in health care [ 58 ], and the “Checklist for Reporting Research using Simulated Patient methodology in Health” (CRiSPHe) [ 59 ] were followed. Mystery callers Eight female master’s students (ABe, AMDr, RGa, HHi, JLa, CPr, KSc, and HSc) from the Department of Health, Nursing, Management at Neubrandenburg University of Applied Sciences served as MCs as part of a three-semester research project free of charge. All MCs spoke standard German and had no prior experience with mystery calls. The MCs were between 21 and 24 years old at the time of data collection. Setting and participation The mystery calls were conducted nationwide in Germany between July 15, 2024, and August 22, 2024. Due to the covert study design, the state chambers of pharmacists were not contacted to provide a comprehensive list of all CPs. Instead, the publicly accessible software of the Federal Pharmacy Register, version 3.6.0.9 (data status: February 2024), was used to determine the target population [ 60 ]. This register contains all German CPs, including name, address (with federal state), and telephone number. A total of 17,583 CPs listed in the register were proportionally stratified by federal state between March 1, 2024, and March 20, 2024. To date, no MC studies in Germany or internationally have examined unnecessary recommendations of oral ECs by CPs. Consequently, the proportion of the characteristic of interest in the target population was unknown. Setting this parameter to P = 0.5 maximizes the required sample size. Using the online sample size calculator “Raosoft” [ 61 ], the following parameters were applied: A population size of N = 17,583, A conventional margin of error (e) of 0.05, A conventional 95% confidence level, and A proportion of the characteristic of interest of P = 0.5. This calculation resulted in a minimum required sample size (n) of 376 CPs. The stratified list of 17,583 CPs was assigned random numbers using the Microsoft Excel random number generator (Microsoft® Excel version 2404, Microsoft Corporation, Redmond, USA). Within each stratum, a simple random sample proportional to the stratum’s share of all CPs was drawn, yielding the required 376 CPs (stratified random sampling). The preliminary sample was further verified as of March 27, 2024, using a Google search performed by the MCs. Only CPs confirmed to be operational were included. This verification ensured the exclusion of CPs that had closed or could not be identified. For each excluded CP, replacements were drawn for the respective federal state using the Excel random number generator. If, despite verification, CPs were unexpectedly closed or unreachable during the execution of the mystery calls, they were replaced ad hoc by additional CPs drawn from the corresponding stratum. Scenario and assessment In an initial step, the MCs familiarized themselves with the theoretical foundations of the SPM. They were supported in this process by BLa, who already had extensive experience with SPM. The two instruments, scenario and assessment form ( Tables 1 and 2 ), were jointly developed by the MCs and BLa based on the BAK guideline [ 17 ]. In particular, the included checklist was used [ 17 ]. This ensured that the participating pharmacy staff would be able to respond appropriately to the described situation. Furthermore, the planned scenario and assessment form underwent content validation by CKu, who also had extensive SPM experience. Two pharmacists who had not been involved in the development of the two instruments also participated in the validation. This validation did not result in any need to adapt the instruments. Download: PNG larger image TIFF original image Table 1. Scenario. https://doi.org/10.1371/journal.pone.0361027.t001 Download: PNG larger image TIFF original image Table 2. Assessment items. https://doi.org/10.1371/journal.pone.0361027.t002 The scenario ( Table 1 ) was designed so that the MC requested oral EC for herself. To initiate the telephone conversation, the MC stated that she was uncertain whether she needed oral EC. The pharmacy staff were then explicitly asked to provide counseling and were expected, in an ideal consultation, to elicit additional information to support the decision-making process. Based on the typology proposed by Collins et al., this represents a product-based scenario [ 45 ]. It was further decided that all MCs would report a uniform age of 24 years during the conversations. This age was considered plausible, given that the primary users of oral ECs are women between 21 and 35 years of age [ 62 ]. The scenario depicts a missed intake of a combined oral contraceptive following sexual intercourse. The pill “Maxim” [ 63 ] was selected as it is reported to be the most frequently dispensed preparation for combined oral contraceptives in Germany [ 64 ]. Requesting oral EC due to a missed intake of the combined oral contraceptive also represents a realistic scenario. For instance, 31.0% of 14- to 25-year-old women surveyed by Scharmanski and Hessling [ 65 ] reported having used oral EC at least once because they had forgotten to take their regular pill. In a comparable survey of pharmacists, Said et al. [ 44 ] even found a proportion of 66.4%. In the scenario described here, sexual intercourse occurs prior to the missed intake of the combined oral contraceptive. Since sperm can remain active in the female body for up to five days [ 66 , 67 ], pregnancy in this situation would theoretically be possible. However, because in the constructed case only a single pill was missed and less than 12 hours had elapsed, the use of oral EC would not be necessary (AO) [ 17 , 68 ]. At the time of the mystery call, the missed pill had not yet been taken. In developing the scenario, care was taken to ensure that, apart from the fact that the 12-hour window for delayed intake of the combined oral contraceptive had not yet elapsed, the conditions for recommending oral EC according to the BAK guideline would otherwise have been met. For this reason, the scenario was constructed so that the MC was in the first week of the pill cycle and sexual intercourse had taken place within the previous five days [ 17 ]. If the consulted pharmacy staff asked the MCs during the call to visit the pharmacy in person, this was uniformly declined, if necessary, using a three-step sequence of justifications. This procedure was intended to minimize the risk of the telephone consultation being discontinued. The quantitative assessment form ( Table 2 ) consists of 21 items. The first 16 items capture whether pharmacy staff ask the questions recommended in the BAK checklist [ 17 ]. Items 17–21 capture the counseling outcome. The AO in this scenario is the recommendation that oral EC is not required (item 18). Item 21 assesses whether the pharmacy staff provide the correct recommendations regarding the continued intake of the combined oral contraceptive, in accordance with the BAK guideline [ 17 ]. Beyond the collection of quantitative data, qualitative data on specific occurrences were also recorded based on free-text responses during the mystery calls (item 22) [ 69 ]. In addition to the items included in the assessment form, the MCs collected numerous variables before, during, and after the mystery calls ( Table 3 ), which, according to the international literature, might influence the AO. Since only items 2, 3, 5, and 6 needed to be addressed in order to identify the AO, a “questioning score” consisting solely of these items was created. This score, also in line with the international literature, was considered a potential influencing factor on the AO ( Table 3 ). A differentiated weighting of the individual items was omitted, as this would have depended on subjective considerations. Download: PNG larger image TIFF original image Table 3. Potential influencing factors, time and type of data collection. https://doi.org/10.1371/journal.pone.0361027.t003 Purchasing power was defined as the disposable income of the population of a region, comprising net income after taxes and social security contributions, including received transfer payments [ 80 ]. It was categorized into three groups (≤ €25,500, €25,501–€29,500, and ≥ €29,501). This variable was included based on the hypothesis that higher local purchasing power may be associated with greater incentives for CPs to recommend comparatively expensive oral EC unnecessarily because customers may be better able to afford it, whereas lower purchasing power may be associated with lower incentives. Data collection The allocation of the selected CPs to the MCs was carried out randomly. Each of the eight MCs was therefore assigned 47 CPs (376 CPs / 8 MCs = 47 CPs). In addition to the main study, a pretest with a total of 40 validation calls was initially conducted. The distribution of five validation calls per MC was likewise determined randomly. Subsequently, a workshop was held to exchange experiences and to provide mutual feedback on the specific characteristics of the scenario and the assessment form. The pretests also demonstrated the need to adapt the scenario. Specifically, the introductory statement was modified to emphasize the MCs’ uncertainty about whether oral EC was required and to explicitly request professional counseling from the pharmacy staff. The revised scenario was then re-tested with two validation calls per MC. Data collection took place on different weekdays
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