26 research outputs found

    Pharmacists' perception of educational material to improve patient safety: A cross-sectional study on practices and awareness in Germany.

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    ABSTRACT: Educational material (EM) addresses particular safety information of medicinal products to healthcare professionals and patients. Since 2016, German national competent authorities label approved EM with a Blue Hand symbol. However, data is scarce regarding its usability as a safety communication tool in pharmacies to improve patient safety. The purpose of this study is to investigate for the first time pharmacists' awareness and perception of EM in the setting of community and hospital pharmacies in Germany.The Drug Commission of German Pharmacists surveyed its nationwide network of 677 community and 51 hospital reference pharmacies, to investigate their awareness and perception of EM. The survey was conducted between January 16 and February 10, 2020 using SurveyMonkey. Data were analyzed using Microsoft Excel.A total of 373 community and 32 hospital pharmacists participated; response rates were 55.1% and 62.8%, respectively. Overall, 320 (85.8%) community and all hospital pharmacists confirmed awareness of EM. Community and hospital pharmacists fully (n = 172, 46.9% and n = 9, 28.1%) or rather (n = 109, 29.7% and n = 10, 31.3%) agreed that EM for healthcare professionals is suitable to reduce risks of medicinal products. Moreover, 237 (64.7%) community and 17 (53.1%) hospital pharmacists confirmed to inform patients or care facilities about EM. Asking pharmacists on their personal perception of EM, the refinement of readability and accessibility was indicated.Pharmacists confirm awareness of EM and its suitability as a safety communication tool. However, from a pharmacists' perspective, the applicability and readability of EM still needs further adjustment to improve patient safety

    Trends in dispensing oral emergency contraceptives and safety issues: a survey of German community pharmacists.

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    Background Oral emergency contraceptives containing levonorgestrel or ulipristal acetate are available without prescription and only in pharmacies in Germany since March 2015. Due to this change community pharmacists are responsible for evaluating whether the product is appropriate and to educate women on proper use. Objective To measure the utilization of emergency contraceptives without a prescription and describe potential concerns and safety issues identified by community pharmacists in Germany. Setting The Drug Commission of German Pharmacists' nationwide network of reference pharmacies which includes 860 community pharmacies. Methods Reference community pharmacies were asked to participate in the eleven-questions online survey. Respondents were asked to recall their experiences with oral emergency contraceptives in the past 3 months. Data were collected between January 8 and February 19, 2018. Main outcome measure The survey focused on the utilization of emergency contraceptives without a prescription in Germany, and on the pharmacists' experiences with (potential) problems and concerns regarding safe use. Results In total, 555 community pharmacies (64.5%) participated. Overall 38.2% of community pharmacists stated they dispensed six to ten courses of emergency contraceptives within the past 3 months. In addition, 54.3% of the pharmacists estimated they dispensed emergency contraceptives exclusively without prescription and 35.9% dispensed more than 30% of emergency contraceptives during night-time and emergency services. Moreover, 82.8% of pharmacists stated that emergency contraceptives were requested not by the women concerned but a third person and 44.3% identified uncertainties in woman's self-diagnosis. Three out of four pharmacists had concerns about the effective and safe use of emergency contraceptives. In situations suggesting sexually transmitted diseases, or suspicion for use of force, 59.5% and 55.8% of the pharmacists, respectively, dispensed emergency contraceptives. In cases of acute health impairment or chronic disease, or (potentially) relevant drug/drug interaction, the vast majority (91.0% and 90.5%) did not. Here, most pharmacists referred to gynecologists. Conclusion Pharmacists had safety concerns when dispensing emergency contraceptives. Professional expertise in evaluating the need for oral emergency contraceptives and the proper use is needed

    Can claims data help validating drug risk signals? A case report

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    Dosierung flüssiger Zubereitungen zum Einnehmen–Potenzial für Medikationsfehler

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    Der Austausch von wirkstoffgleichen Arzneimitteln kann bei flüssigen Zubereitungen zu Missverständnissen bei der Dosierung führen, was in den unterschiedlichen Wirkstoffkonzentrationen und/oder Applikationshilfen begründet sein kann. Medikationsfehler mit schwerwiegenden gesundheitlichen Folgen für Patienten können die Folge sein. Daher müssen die am Medikationsprozess Beteiligten sowohl bezüglich der Gefahr von Dosierungsfehlern als auch der fehlerbegleitenden Umstände, die Fehldosierungen (mit)bedingen können, sensibilisiert werden. Nur durch ausreichende Kenntnis kann es den Angehörigen der Heilberufe gelingen, entsprechende Maßnahmen in ihrer täglichen Praxis zu etablieren, um (potenziellen) Risiken für Patienten konsequent entgegenzuwirken. Das BfArM arbeitet daher u.a. eng mit den Arzneimittelkommissionen der Heilberufe, wie z.B. der Arzneimittelkommission der Deutschen Apotheker (AMK), sowie den Zulassungsinhabern zusammen, um Maßnahmen zu eruieren, die das Risiko eines (potenziellen) Dosierungsfehlers reduzieren können. Der folgende Artikel gibt hierzu eine Zusammenschau relevanter Fallbeispiele aus der Praxis, die dem BfArM bzw. der AMK berichtet wurden. Diese sollen die gebotene Aufmerksamkeit bei einem Austausch von Arzneimitteln und einer damit einhergehenden Änderung der Dosierungsanweisung, insbesondere bei Lösungen, verdeutlichen und sowohl die Möglichkeiten als auch Grenzen der jeweiligen (regulatorischen) Maßnahmen zur Risikominimierung aufzeigen

    Medikationsfehler in der Praxis: Die Bedeutung von Look- und Soundalikes als Mitursache von Medikationsfehlern

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    Die Verwechslung ähnlich klingender Arzneimittelnamen oder ähnlich aussehender Verpackungen/Verpackungsdesigns beziehungsweise Schriftbilder (sog. Lookalikes und Soundalikes, LASA) kann zu Medikationsfehlern aufgrund einer falschen Wirkstoff- bzw. Arzneimittelanwendung oder aufgrund von Dosierungsfehlern führen und somit ein ernstes, sogar potenziell lebensbedrohendes Risiko für Patienten darstellen. Medikationsfehler sind grundsätzlich vermeidbar. Umso wichtiger ist es, Arzneimittel mit ähnlich klingenden Namen und/oder ähnlich aussehenden Schriftbildern oder Verpackungen zu identifizieren. Das BfArM hat dazu eine Liste aller diesbezüglichen Meldungen ab 2012 zusammengestellt, die auf Anfrage zur Verfügung gestellt werden kann. Falls Medikationsfehler durch Kennzeichnungen bzw. Aufmachungen mitverursacht werden, kann das BfArM, idealerweise zusammen mit den Zulassungsinhabern und den Meldenden, Lösungen erarbeiten, um solchen fehlerbeitragenden Faktoren entgegenzutreten. Im Folgenden werden einige Beispiele von Medikationsfehlern beschrieben, die sowohl dem BfArM als auch der AMK berichtet worden sind und die Notwendigkeit eindeutiger Angaben in der Arzneimittelbezeichnung bzw. der Packmittelaufmachung unterstreichen. Aber nicht allen potenziellen Verwechslungsgefahren kann regulatorisch entgegengewirkt werden. Hierbei sind zwingend die Evidenz der Verwechslungsgefahr, der Zulassungs- und Verschreibungsstatus des Arzneimittels (u.a. Verfahrensart, Alter und die Hauptverantwortung für die Zulassungserteilung), die Verhältnismäßigkeit der anzustoßenden Maßnahme sowie das Zusammenwirken mit der pharmazeutischen Industrie zu berücksichtigende Faktoren, die den Erfolg einer regulatorischen Maßnahme maßgeblich mitbestimmen

    Antwort zum Leserbrief

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    Drug shortages may compromise patient safety: Results of a survey of the reference pharmacies of the Drug Commission of German Pharmacists.

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    Drug shortages are a complex problem and of growing concern. To evaluate implications of drug shortages in terms of outpatient and inpatient safety, the Drug Commission of German Pharmacists surveyed its two nationwide reference pharmacy networks: 865 community and 54 hospital pharmacies. Participants were asked to complete a six-question online survey, covering relevance and challenges of drug shortages in everyday practice as well as consequences for patient safety. Answers were given in the context of the last three months prior to the survey. In total, 482 community (55.7%) and 36 hospital pharmacies (66.7%) participated. Occurrence of drug shortages were confirmed by 88.6% of community and 80.6% of hospital pharmacies. Thus, for example, a substitute was dispensed more than 15 times (60.7% of community, 44.8% of hospital pharmacies) during the 3-month-period. Comparing community and hospital pharmacies, differences in the incidence or severity of consequences for patient safety were apparent. Community pharmacies mainly confirmed adverse effects on patients' medication adherence (60.4%) and treatment discontinuation (25.8%). A delay or deny of a life-saving treatment (39.4%) was largely reported by hospital pharmacies. Medication errors were reported by 20.1% of the community and 21.2% of the hospital pharmacies, respectively. Taken together, sustainable solutions are needed to counteract drug shortages and to ensure adequate treatment for patients
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