RESUMEN

The simulated patient methodology (SPM) is considered the "gold standard" as covert participatory observation. SPM is attracting increasing interest for the investigation of community pharmacy practice; however, there is criticism that SPM can only show a small picture of everyday pharmacy practice and therefore has limited external validity. On the one hand, a certain design and application of the SPM goes hand in hand with an increase in external validity. Even if, on the other hand, this occurs at the expense of internal validity due to the trade-off situation, the justified criticism of the SPM for investigating community pharmacy practice can be countered.

RESUMEN

BACKGROUND: In Germany, over-the-counter (OTC) medicines may only be dispensed by community pharmacies (CPs). German CPs must ensure 'adequate' counselling, including the cost of medicines. Along with information gathering and advice giving as classic aspects of counselling, the aim was also to investigate counselling indicators of product and price transparency. METHODS: The cross-sectional study was based on the covert simulated patient (SP) methodology and was conducted in a random sample of CPs stratified by districts in the major German city of Munich. Each of the 178 selected CPs was visited once by one of five trained female students. They simulated a symptom-based sub-scenario 1 with a request for an OTC medicine for a headache and a sub-scenario 2 with standardised information regarding product and price transparency. The assessment, completed immediately postvisit by the SPs, included a total of 23 items. RESULTS: All 178 scheduled visits were completed successfully. The median counselling score with the classic items was 3.0 out of 12 points (interquartile range [IQR] 4.25) and when expanded by items for product and price transparency the score was 4.0 out of 14 points (IQR 4.00). A selection of medicines was offered unsolicited in 38.2% of the visits and in 5.6% of the visits voluntary price information was provided before the transaction. A request for a cheaper medicine led to a significant price reduction (Wilcoxon signed-rank test; p < 0.001, r = 0.869). CONCLUSION: Due to the below-average level of counselling, the regional chambers of pharmacists are recommended to initiate measures for improvement. There is also potential for optimisation with regard to product and price transparency as an important extension of the classic counselling aspects. It is therefore recommended that the government raise customers' awareness of the cost of medicines.

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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

Community pharmacies (CPs) play a major role in health care delivery. The simulated patient methodology (SPM), which is considered the "gold standard", is recommended for studying CP practice. SPM can be applied in different forms, which include visits and also calls ("mystery calls"). So far, only the role of visits in the investigation of CP practice is known. As the first study worldwide, a systematic map of such reports will be provided, which applies calls in the context of the SPM for the study of CP practice. Reports with the pharmacy staff as the population under study should be included. Reports should be included that conduct an investigation using the SPM in the form of calls to simulate patients and other customers. Reports should be included that examine CP practice as defined by the International Pharmaceutical Federation and the World Health Organization (FIP/WHO). The scoping review methodology will be applied using the associated guidelines from Joanna Briggs Institute (JBI) and PRISMA extension for Scoping Review (PRISMA-ScR). The search will be for both published and unpublished original research in English with transparent information on SPM until the end of 2022. The plan is to search Embase, MEDLINE via PubMed, and Web of Science. Directly afterward, the respective literature collection of the reviewers and the reference lists of suitable international reviews will be searched. This will be followed by a forward and backward snowballing in Google Scholar. For the inclusion of reports, a selection process and for the data extraction a data charting process with the help of variables derived from related reviews and from two SPM-form spanning international guidelines will be performed. The data extracted from the included reports should be synthesized and presented in MS Excel tabular form using the previously determined variables.

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Background: In Germany-as worldwide-headache is one of the most frequent causes of self-medication. The dispensing of over-the-counter (OTC) medications may only be carried out by community pharmacies (CPs). In doing so, CPs have to ensure "adequate" counseling, for both self-purchase and purchase for a third party, which also occurs in everyday pharmacy practice. The aim of this study was to evaluate the quality of counseling for headache OTC medications in German CPs and, as the first study worldwide, to analyze whether and to what extent there are differences in counseling between self-purchase and purchase for a third party. Methods: A cross-sectional study was carried out using the covert simulated patient methodology (SPM) in all 42 CPs in the German big city Potsdam. With the help of 8 trained simulated patients (SPs), each CP was visited four times by a different SP. The SPs simulated in each CP two scenarios two times with the demand for an OTC medication against headache, which differed only in whether the demand was for themselves or for their boyfriend/girlfriend. Results: All 168 planned pharmacy visits (84 visits per scenario) were successfully carried out. Overall, the median counseling score was 3.0 out of 9 points (interquartile range [IQR 2.0]). There were no significant differences between the two scenarios (Wilcoxon signed-rank test; p=0.495, r = 0.053). In a multivariate binary logistic regression analysis, the counseling level and the different scenarios were not significantly associated (adjusted odds ratio [AOR] = 1.635, 95% CI = 0.673-3.972, p=0.278). Conclusions: Due to the partly considerable deficits in counseling of German CPs, policy-makers and the regional chambers of pharmacists are called upon to take appropriate measures to improve the quality of counseling. It is positive that no differences in counseling between self-purchase and purchase for a third party were found, but further verifying studies with a modified methodology are recommended.

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Background: In Germany, over-the-counter (OTC) medicines for self-medication may only be dispensed by community pharmacies (CPs). From the customer's point of view, "adequate" counseling includes not only the recommendation of medicines that meet guidelines, but also the dispensing of low-priced medicines. This is all the more important in Germany against the background of free pricing and a lack of obligation to display prices. The aim was to analyze the dispensing and possible price variability of OTC medicines for headache. Methods: The cross-sectional design of the study based on the simulated patient methodology (SPM) included all 42 CPs of the German big city Potsdam and used eight trained simulated patients (SPs). Between October and December 2020, four different SPs visited each CP four times with two almost identical scenarios with the demand for a medicine for headache. Results: All 168 planned visits were successfully completed and ibuprofen (60.1%) was dispensed most frequently. Across all dispensed medicines, prices varied from €0.93 to €9.97 (∆ 972%; median €3.46 [interquartile range (IQR) €2.25]). For repeated dispensing of the same CPs, the price variability was a maximum of €8.77. In addition, packs with ≤10 tablets were dispensed in 47.6%, with 11 to 20 tablets in 50.6%, and with >20 tablets in 1.8% of visits. Conclusion: Increasing price transparency and strengthening price competition could make it easier for customers to access OTC medicines according to their personal needs.

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To prevent unwanted pregnancies, oral emergency contraception (EC) with the active ingredients levonorgestrel (LNG) and ulipristal acetate (UPA) is recommended by the guidelines of the German Federal Chamber of Pharmacists (BAK). In this respect, community pharmacies (CPs) in Germany have a major responsibility for information gathering, selecting the appropriate medicine, availability and pricing, among other things. Therefore, it would be appropriate to conduct a study with the aim of investigating information gathering, a possible recommendation as well as availability and pricing for oral EC in German CPs. A representative nationwide observational study based on the simulated patient methodology (SPM) in the form of covert mystery calls will be conducted in a random sample of German CPs stratified according to the 16 federal states. Each selected CP will be randomly called once successfully by one of six both female and male trained mystery callers (MCs). The MCs will simulate a product-based scenario using the request for oral EC. For quality assurance of the data collection, a second observer accompanying the MC is planned. After all mystery calls have been made, each CP will receive written, pharmacy-specific performance feedback. 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. International studies suggest that UPA in particular is not always available. Significant price differences could be found analogous to another German study for a different indication.

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BACKGROUND: In Germany over-the-counter medications (OTC) - which since 2004 are no longer subject to binding prices - can only be purchased in pharmacies. Pharmacy owners and their staff therefore have a special responsibility when dispensing, advising on and setting the prices of medications. OBJECTIVE: The aim of this study was to assess medication dispensing, additional therapeutic recommendations and pricing practices for acute diarrhoea in adults and to evaluate the role of the patient's approach (symptom-based versus medication-based request) in determining the outcome of these aspects. METHODS: A cross-sectional study was conducted from 1 May to 31 July 2017 in all 21 community pharmacies in a medium-sized German city. Symptom-based and medication-based scenarios related to self-medication of acute diarrhoea were developed and used by five simulated patients (SPs) in all of the pharmacies (a total of 84 visits). Differentiating between the different test scenarios in terms of the commercial and active ingredient names and also the prices of the medications dispensed, the SPs recorded on collection forms whether the scenario involved generic products or original preparations as well as whether recommendations were made during the test purchases regarding an additional intake of fluids. RESULTS: In each of the 84 test purchases one preparation was dispensed. However, a preparation for oral rehydration was not sold in a single test purchase. On the other hand, in 74/84 (88%) of test purchases, medications with the active ingredient loperamide were dispensed. In only 35/84 (42%) of test purchases, the patient was also recommended to ensure an 'adequate intake of fluids' in addition to being dispensed a medication. In symptom-based scenarios significantly more expensive medications were dispensed compared to the medication-based scenarios (Wilcoxon signed rank test: z = -4.784, p < 0.001, r = 0.738). Also within the different scenarios there were enormous price differences identified - for example, in the medication-based scenarios, even for comparable loperamide generics the cheapest preparation cost EUR 1.99 and the most expensive preparation cost EUR 4.53. CONCLUSIONS: Oral rehydration was not dispensed and only occasionally was an adequate intake of fluids recommended. There were also enormous price differences both between and within the scenarios investigated.

RESUMEN

Background: In Germany over-the-counter medications (OTC) - which since 2004 are no longer subject to binding prices - can only be purchased in pharmacies. Pharmacy owners and their staff therefore have a special responsibility when dispensing, advising on and setting the prices of medications. Objective: The aim of this study was to assess medication dispensing, additional therapeutic recommendations and pricing practices for acute diarrhoea in adults and to evaluate the role of the patient's approach (symptom-based versus medication-based request) in determining the outcome of these aspects. Methods: A cross-sectional study was conducted from 1 May to 31 July 2017 in all 21 community pharmacies in a medium-sized German city. Symptom-based and medication-based scenarios related to self-medication of acute diarrhoea were developed and used by five simulated patients (SPs) in all of the pharmacies (a total of 84 visits). Differentiating between the different test scenarios in terms of the commercial and active ingredient names and also the prices of the medications dispensed, the SPs recorded on collection forms whether the scenario involved generic products or original preparations as well as whether recommendations were made during the test purchases regarding an additional intake of fluids. Results: In each of the 84 test purchases one preparation was dispensed. However, a preparation for oral rehydration was not sold in a single test purchase. On the other hand, in 74/84 (88%) of test purchases, medications with the active ingredient loperamide were dispensed. In only 35/84 (42%) of test purchases, the patient was also recommended to ensure an 'adequate intake of fluids' in addition to being dispensed a medication. In symptom-based scenarios significantly more expensive medications were dispensed compared to the medication-based scenarios (Wilcoxon signed rank test: z = -4.784, p < 0.001, r = 0.738). Also within the different scenarios there were enormous price differences identified - for example, in the medication-based scenarios, even for comparable loperamide generics the cheapest preparation cost EUR 1.99 and the most expensive preparation cost EUR 4.53. Conclusions: Oral rehydration was not dispensed and only occasionally was an adequate intake of fluids recommended. There were also enormous price differences both between and within the scenarios investigated

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Background: In Germany, non-pharmacists (pharmacy technicians and pharmaceutical technical assistants) are permitted to advise on and sell medications in addition to pharmacists. The aim of this study was to determine if pharmacists and non-pharmacists referred patients to a medical consultation for a scenario in which consulting a doctor was mandatory ('appropriate outcome') and what the quality of questioning and - if a medication was dispensed - the quality of information provided were in this context. The study also aimed to determine which factors predicted a necessary referral to a doctor. Methods: A cross-sectional, covert simulated patient study was conducted in a random sample of community pharmacies stratified by location in the German state of Mecklenburg-Vorpommern. Each pharmacy was visited once by one of four trained investigators. They simulated a symptom-based request involving a grandmother with acute diarrhoea. A multivariate binary logistic regression analysis using potential variables from bivariate analysis was carried out to determine the predictors for a referral to a doctor. Results: All 199 planned visits were conducted. A necessary referral to a doctor was recommended in 59.8% (n=119) of all visits. The most commonly asked question was 'for whom is the medication?' (75.4%, n=150), while 'clarification by a doctor' was asked the least (17.6%, n=35). In 87.9% (n=175) of all visits a medication was dispensed. Multivariate analysis revealed that, unlike pharmacists, non-pharmacists have a 2.446 times higher likelihood of recommending a referral to a doctor (p = 0.044; 95% CI = 1.025-5.835). Conclusions: In almost half of the visits a necessary referral to a doctor was not recommended. Furthermore, the quality of questioning and the quality of information were below expectations. Moreover, involvement of non­pharmacists was surprisingly identified as a relevant factor influencing the appropriate outcome.