Characteristics and completeness of spontaneous reports by reporter's role in Germany: An analysis of the EudraVigilance database using the example of opioid-associated abuse, dependence, or withdrawal.

ABSTRACT: Spontaneous reporting is based on the experience of all healthcare professionals (HCPs) but also consumers/non-HCPs and therefore reveals a broad picture of a drug's adverse reactions. Recent studies found substantial differences between reports from these varying sources including the reports' completeness. Using the example of opioid-associated abuse, dependence, or withdrawal, this study analyzed the completeness and characteristics of spontaneous reports from Germany focusing on the reporter. Based on EudraVigilance data, we included all cases of abuse, dependence, or withdrawal associated with opioids indicated for pain therapy and filed from Germany until 2018. Completeness and characteristics were analyzed by a reporter (physician, pharmacist, other HCPs, consumers/non-HCPs) and als

SUBMITTER: Jobski K 

PROVIDER: S-EPMC10036728 | biostudies-literature | 2023 Apr

REPOSITORIES: biostudies-literature