gms | German Medical Science

29. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie (GAA)

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie

24.11. - 25.11.2022, Münster

Characteristics and completeness of spontaneous reports of opioid-associated abuse, dependence or withdrawal based on EudraVigilance data in Germany: Reporting characteristics of pharmacists and other reporters

Charakteristika und Vollständigkeit von Spontanmeldungen zu Missbrauch, Abhängigkeit und Entzug im Zusammenhang mit Opioiden in Deutschland basierend auf EudraVigilance-Daten: Meldecharakteristika von Apotheker*innen und anderen meldenden Personen

Meeting Abstract

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  • corresponding author presenting/speaker Kathrin Jobski - Department of Health Services Research, Carl von Ossietzky University Oldenburg, Oldenburg, Germany
  • author Carsten Bantel - University Department of Anesthesiology, Critical Care, Emergency and Pain Medicine, Klinikum Oldenburg, Oldenburg, Germany
  • author Falk Hoffmann - Department of Health Services Research, Carl von Ossietzky University Oldenburg, Oldenburg, Germany

Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie e.V. (GAA). 29. Jahrestagung der Gesellschaft für Arzneimittelanwendungsforschung und Arzneimittelepidemiologie. Münster, 24.-25.11.2022. Düsseldorf: German Medical Science GMS Publishing House; 2022. Doc22gaa08

doi: 10.3205/22gaa08, urn:nbn:de:0183-22gaa086

Veröffentlicht: 21. November 2022

© 2022 Jobski et al.
Dieser Artikel ist ein Open-Access-Artikel und steht unter den Lizenzbedingungen der Creative Commons Attribution 4.0 License (Namensnennung). Lizenz-Angaben siehe http://creativecommons.org/licenses/by/4.0/.


Gliederung

Text

Background: Spontaneous reporting is a mainstay of pharmacovigilance. It is based on the experience of physicians, pharmacists and other health care professionals (HCP) but also consumers therefore revealing a broad picture of adverse drug reactions (ADR). Data on differences between reports from these different person groups including the reports’ completeness is scarce. Using the example of opioid-associated abuse, dependence or withdrawal, this study analyzed the completeness and characteristics of spontaneous reports from Germany focusing on pharmacists and other reporters.

Materials and Methods: Based on EudraVigilance data, we included all cases of abuse, dependence or withdrawal associated with commonly used opioids indicated for pain therapy and filed from Germany until 2018. We analyzed case characteristics by reporter (physician, pharmacist, other HCPs, consumer) and displayed time trends by reporter and opioid(s). Further, proportions of completeness were calculated for selected characteristics such as demographics, indication/comorbidity or duration of opioid use.

Results: In total, 1,721 cases were included, mainly filed by physicians (38.5%) and pharmacists (30.7%). Other HCP filed 14.1% and consumers 12.0% of reports, respectively. Completeness of demographics varied from 74.5% (other HCPs) to 42.7% (consumers). Consumers most often provided any indication/comorbidity (75.2%) and the ADR’s outcome (59.2%) whereas these items were least complete in pharmacy-filed reports (20.2% and 17.6%, respectively). The duration of opioid use was reported by 36.5% of physicians and only 4.5% of pharmacists. Large differences between the reporters were found for almost all characteristics. Other HCPs far more often coded a history of drug abuse, dependence or withdrawal than all other person groups (46.9% vs. 11.6-24.2%, respectively) and fatal outcomes were also mainly filed by other HCPs (68.1% vs. 14.8%-20.4% by all other person groups). Differences were also observed between the mainly reported opioids (tramadol in physicians and consumers, tilidine in pharmacists and morphine in other HCPs). The reported duration of opioid use (based on the information of 379 reports) varied between 1 day (physicians, other HCPs), 52 days (pharmacists) and 366 days (consumers).

Conclusion: Cases of opioid-associated abuse, dependence or withdrawal differed substantially depending on the reporter. Differences were observed in terms of clienteles/settings, demographics and other characteristics but also with respect to the completeness of the reported items. Therefore, in analyses based on spontaneous reporting data information on the reporters should be included. Finally, despite the more limited availability of information in German pharmacies compared to other settings, pharmacists may be encouraged to report ADRs more completely.