Incomplete Spontaneous Reporting Data as a Barrier to Safety Assessment: A Retrospective Study of Osteoporosis Pharmacotherapy

INTRODUCTION. Spontaneous reporting is a principal tool for obtaining information on adverse drug reactions (ADRs). However, incomplete entry of key fields in ADR report forms by reporters complicates causality assessment. The adequacy of available information for an objective causality assessment and pharmacovigilance decision-making, especially for drugs taken long-term, remains debatable. Osteoporosis was chosen as an example of a disease requiring long-term therapy, which increases the risks of adverse drug reactions and reduces treatment adherence.

AIM. This study aimed to evaluate the completeness of key fields in ADR report forms for drugs used in the treatment of osteoporosis within the Russian pharmacovigilance system and to determine the impact of missing information on the ability to perform causality assessment and assess treatment safety.

MATERIALS AND METHODS. A total of 1,802 spontaneous ADR reports for osteoporosis drugs were analyzed. The reports were registered in the Pharmacovigilance database of Roszdravnadzor’s Automated Information (the AIS Roszdravnadzor), versions 1.0 (2009–2019) and 2.0 (2019–2024). The proportion of missing data in each field was calculated.

RESULTS. Field completion varied widely. In version 1.0, missing data ranged from 1.15% (Anatomical Therapeutic Chemical classification code) to 74.0% (ADR resolution date); in version 2.0, from 2.4% (sex) to 65.9% (ADR resolution date). In both versions, basic patient characteristics (sex, age) were consistently reported, whereas start/end dates of pharmacotherapy, outcomes, and manufacturer were frequently missing. Compared with version 1.0, version 2.0 showed improved completion of clinical ADR fields but more missing data in “Manufacturer” and “Batch number”. The transition to version 2.0 produced mixed effects: fewer mandatory fields expanded reporting of ADR characteristics but reduced details needed for causality assessment.

CONCLUSIONS. The analysis of spontaneous reports revealed systematic gaps in ADR report forms for osteoporosis pharmacotherapy, hindering causality assessment. To improve pharmacovigilance and risk management, especially in patients with chronic diseases, standardization of data collection protocols is required, including mandatory completion of critical fields (ADR onset/resolution dates, concomitant therapy, actions taken, dechallenge/rechallenge outcomes) and targeted reporter education.

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