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The possible harms of statins: What do product labels, patient package inserts, and pharmacy leaflets tell us?

Publication ,  Journal Article
Doshi, P; Sieluk, J; Hung, A
Published in: J Am Pharm Assoc (2003)
2019

OBJECTIVES: To evaluate the degree to which health care professionals and patients receive consistent messages regarding the possible harms of statins. DESIGN: Cross-sectional study of prescribing information (PI), patient package inserts (PPIs), and pharmacy leaflets for 8 statins approved by the U.S. Food and Drug Adminstration. SETTING: Not applicable. PARTICIPANTS: Not applicable. MAIN OUTCOME MEASURES: All passages describing 7 adverse events (diarrhea, arthralgia, dyspepsia, confusion, memory loss, rhabdomyolysis, and kidney failure) were extracted from PIs, PPIs, and pharmacy leaflets. For each type of information source and adverse event (drug-harm pair), 2 reviewers independently judged passages as indicating either a confirmed, unconfirmed, or mixed causal relationship between statin and adverse event (drug-harm pair). Disagreements were resolved through consensus, and the consistency between information sources was calculated. RESULTS: PI and PPI consistently conveyed the relationship between a given statin and given adverse event (either both "confirmed" or both "unconfirmed") in 12 of 17 evaluable drug-harm pairs. PPIs and pharmacy leaflets were consistent in 10 of 10 evaluable drug-harm pairs. PIs indicated a confirmed, causal relationship in 15 drug-harm pairs that were not mentioned in pharmacy leaflets. Likewise, PPIs indicated a confirmed, causal relationship in 7 drug-harm pairs that were not listed in pharmacy leaflets. CONCLUSION: Despite the widespread use of statins, we discovered considerable ambiguity in language used to describe the evidence concerning their possible harms and variable consistency between PIs, PPIs, and pharmacy leaflets. Further study is needed to understand the reason why pharmacy leaflets did not list, in 15 cases, adverse events that PIs indicated were causally related to the statin.

Duke Scholars

Published In

J Am Pharm Assoc (2003)

DOI

EISSN

1544-3450

Publication Date

2019

Volume

59

Issue

2

Start / End Page

195 / 201

Location

United States

Related Subject Headings

  • Pharmacology & Pharmacy
  • Pharmaceutical Services
  • Pamphlets
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Humans
  • Drug Labeling
  • Cross-Sectional Studies
  • 4203 Health services and systems
  • 1117 Public Health and Health Services
  • 1115 Pharmacology and Pharmaceutical Sciences
 

Citation

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Doshi, P., Sieluk, J., & Hung, A. (2019). The possible harms of statins: What do product labels, patient package inserts, and pharmacy leaflets tell us? J Am Pharm Assoc (2003), 59(2), 195–201. https://doi.org/10.1016/j.japh.2018.12.003
Doshi, Peter, Jan Sieluk, and Anna Hung. “The possible harms of statins: What do product labels, patient package inserts, and pharmacy leaflets tell us?J Am Pharm Assoc (2003) 59, no. 2 (2019): 195–201. https://doi.org/10.1016/j.japh.2018.12.003.
Doshi P, Sieluk J, Hung A. The possible harms of statins: What do product labels, patient package inserts, and pharmacy leaflets tell us? J Am Pharm Assoc (2003). 2019;59(2):195–201.
Doshi, Peter, et al. “The possible harms of statins: What do product labels, patient package inserts, and pharmacy leaflets tell us?J Am Pharm Assoc (2003), vol. 59, no. 2, 2019, pp. 195–201. Pubmed, doi:10.1016/j.japh.2018.12.003.
Doshi P, Sieluk J, Hung A. The possible harms of statins: What do product labels, patient package inserts, and pharmacy leaflets tell us? J Am Pharm Assoc (2003). 2019;59(2):195–201.
Journal cover image

Published In

J Am Pharm Assoc (2003)

DOI

EISSN

1544-3450

Publication Date

2019

Volume

59

Issue

2

Start / End Page

195 / 201

Location

United States

Related Subject Headings

  • Pharmacology & Pharmacy
  • Pharmaceutical Services
  • Pamphlets
  • Hydroxymethylglutaryl-CoA Reductase Inhibitors
  • Humans
  • Drug Labeling
  • Cross-Sectional Studies
  • 4203 Health services and systems
  • 1117 Public Health and Health Services
  • 1115 Pharmacology and Pharmaceutical Sciences