Under-Reporting of Adverse Drug Reactions¶
Hazell, L., & Shakir, S. A. W. (2006). Under-Reporting of Adverse Drug Reactions: A Systematic Review. Drug Safety, 385-396.
Cited by¶
3 citations across 3 artifacts.
Each citation links to the sentence it supports in the citing article.
Primes¶
- Selection-Visibility Gate
- A recessive allele, an untested error branch, an unreported side effect and a shift no inspector happens to visit are all apertures, and only some of them have anyone to blame.
This sourceFinds a median under-reporting rate of 94 percent across 37 studies in 12 countries, an aperture produced by ordinary reporting practice rather than by concealment.
- A recessive allele, an untested error branch, an unreported side effect and a shift no inspector happens to visit are all apertures, and only some of them have anyone to blame.
- Silence as Signal
- Adverse-event reporting. Unreported drug events — reporting being voluntary and costly — are absent from spontaneous reporting systems, so analysts treating absence as safety underestimate true incidence.
This sourceDocuments systematic under-reporting in voluntary adverse-event systems, so absence of reports understates true incidence.
- Adverse-event reporting. Unreported drug events — reporting being voluntary and costly — are absent from spontaneous reporting systems, so analysts treating absence as safety underestimate true incidence.
Domain-specific¶
- Outbreak Underascertainment
- That is why it operates as mechanism in foodborne and waterborne outbreak surveillance (CDC under-diagnosis and under-reporting multipliers for Salmonella, Campylobacter and norovirus), adverse-drug-event pharmacovigilance (Hazell and Shakir's systematic review found a median 94% under-reporting rate to spontaneous systems, interquartile range 82–98% — a median of about 6% of adverse drug reactions reported, with FAERS and EudraVigilance understood as undercounts), and occupational-injury reporting (OSHA-recordable counts as a known undercount with an incident → reported → recorded → entered pyramid), and partially in mass-shooting and hate-crime data (definitional and reporting attenuation across jurisdictions)
This sourceHazell and Shakir's systematic review is the measurement behind the pharmacovigilance clause and only that clause: a median 94% under-reporting rate to spontaneous systems across 37 studies in 12 countries (IQR 82-98%), i.e. a median of about 6% of adverse drug reactions reported, serious reactions included; the foodborne, OSHA and crime-data clauses in the same sentence are sourced elsewhere, and FAERS and EudraVigilance are not discussed here.
Supported in partVerified against the source
- That is why it operates as mechanism in foodborne and waterborne outbreak surveillance (CDC under-diagnosis and under-reporting multipliers for Salmonella, Campylobacter and norovirus), adverse-drug-event pharmacovigilance (Hazell and Shakir's systematic review found a median 94% under-reporting rate to spontaneous systems, interquartile range 82–98% — a median of about 6% of adverse drug reactions reported, with FAERS and EudraVigilance understood as undercounts), and occupational-injury reporting (OSHA-recordable counts as a known undercount with an incident → reported → recorded → entered pyramid), and partially in mass-shooting and hate-crime data (definitional and reporting attenuation across jurisdictions)
Verification¶
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