Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA

Research output: Contribution to journalJournal articleResearchpeer-review

Standard

Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA. / Eriksson, Robert; Aagaard, Lise; Jensen, Lars Juhl; Borisova, Liza ; Hørlück, Dorte; Brunak, Søren; Hansen, Ebba Holme.

In: Pharmacology Research & Perspectives, Vol. 2, No. 3, e00038, 2014, p. 1-10.

Research output: Contribution to journalJournal articleResearchpeer-review

Harvard

Eriksson, R, Aagaard, L, Jensen, LJ, Borisova, L, Hørlück, D, Brunak, S & Hansen, EH 2014, 'Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA', Pharmacology Research & Perspectives, vol. 2, no. 3, e00038, pp. 1-10. https://doi.org/10.1002/prp2.38

APA

Eriksson, R., Aagaard, L., Jensen, L. J., Borisova, L., Hørlück, D., Brunak, S., & Hansen, E. H. (2014). Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA. Pharmacology Research & Perspectives, 2(3), 1-10. [e00038]. https://doi.org/10.1002/prp2.38

Vancouver

Eriksson R, Aagaard L, Jensen LJ, Borisova L, Hørlück D, Brunak S et al. Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA. Pharmacology Research & Perspectives. 2014;2(3):1-10. e00038. https://doi.org/10.1002/prp2.38

Author

Eriksson, Robert ; Aagaard, Lise ; Jensen, Lars Juhl ; Borisova, Liza ; Hørlück, Dorte ; Brunak, Søren ; Hansen, Ebba Holme. / Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA. In: Pharmacology Research & Perspectives. 2014 ; Vol. 2, No. 3. pp. 1-10.

Bibtex

@article{6bd0194817a24799a5da8d1ea9ea4f86,
title = "Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA",
abstract = "Pharmaceutical product information (PI) supplied by the regulatory authorities serves as a source of information on safe and effective use of drugs. The objectives of this study were to qualitatively and quantitatively compare PIs for selected drugs marketed in both Denmark and the USA with respect to consistency and discrepancy of listed adverse drug reaction (ADR) information. We compared individual ADRs listed in PIs from Denmark and the USA with respect to type and frequency. Consistency was defined as match of ADRs and of ADR frequency or match could not be ruled out. Discrepancies were defined as ADRs listed only in one country or listed with different frequencies. We analyzed PIs for 40 separate drugs from ten therapeutic groups and assigned the 4003 identified ADRs to System Organ Classes (Medical Dictionary for Regulatory Activities [MedDRA] terminology). Less than half of listed ADRs (n = 1874; 47{\%}) showed consistency. Discrepancies (n = 2129; 53{\%}) were split into ADRs listed only in the USA (n = 1558; 39{\%}), ADRs listed only in Denmark (n = 325; 8{\%}) and ADRs listed with different frequencies (n = 246; 6{\%}). The majority of listed ADRs were of the type “gastrointestinal disorders” and “nervous system disorders”. Our results show great differences in PIs for drugs approved in both Denmark and the USA illuminating concerns about the credibility of the publicly available PIs. The results also represent an argument for further harmonization across borders to improve consistency between authority-supplied information.",
author = "Robert Eriksson and Lise Aagaard and Jensen, {Lars Juhl} and Liza Borisova and Dorte H{\o}rl{\"u}ck and S{\o}ren Brunak and Hansen, {Ebba Holme}",
year = "2014",
doi = "10.1002/prp2.38",
language = "English",
volume = "2",
pages = "1--10",
journal = "Pharmacology Research & Perspectives",
issn = "2052-1707",
publisher = "JohnWiley & Sons Ltd",
number = "3",

}

RIS

TY - JOUR

T1 - Discrepancies in listed adverse drug reactions in pharmaceutical product information supplied by the regulatory authorities in Denmark and the USA

AU - Eriksson, Robert

AU - Aagaard, Lise

AU - Jensen, Lars Juhl

AU - Borisova, Liza

AU - Hørlück, Dorte

AU - Brunak, Søren

AU - Hansen, Ebba Holme

PY - 2014

Y1 - 2014

N2 - Pharmaceutical product information (PI) supplied by the regulatory authorities serves as a source of information on safe and effective use of drugs. The objectives of this study were to qualitatively and quantitatively compare PIs for selected drugs marketed in both Denmark and the USA with respect to consistency and discrepancy of listed adverse drug reaction (ADR) information. We compared individual ADRs listed in PIs from Denmark and the USA with respect to type and frequency. Consistency was defined as match of ADRs and of ADR frequency or match could not be ruled out. Discrepancies were defined as ADRs listed only in one country or listed with different frequencies. We analyzed PIs for 40 separate drugs from ten therapeutic groups and assigned the 4003 identified ADRs to System Organ Classes (Medical Dictionary for Regulatory Activities [MedDRA] terminology). Less than half of listed ADRs (n = 1874; 47%) showed consistency. Discrepancies (n = 2129; 53%) were split into ADRs listed only in the USA (n = 1558; 39%), ADRs listed only in Denmark (n = 325; 8%) and ADRs listed with different frequencies (n = 246; 6%). The majority of listed ADRs were of the type “gastrointestinal disorders” and “nervous system disorders”. Our results show great differences in PIs for drugs approved in both Denmark and the USA illuminating concerns about the credibility of the publicly available PIs. The results also represent an argument for further harmonization across borders to improve consistency between authority-supplied information.

AB - Pharmaceutical product information (PI) supplied by the regulatory authorities serves as a source of information on safe and effective use of drugs. The objectives of this study were to qualitatively and quantitatively compare PIs for selected drugs marketed in both Denmark and the USA with respect to consistency and discrepancy of listed adverse drug reaction (ADR) information. We compared individual ADRs listed in PIs from Denmark and the USA with respect to type and frequency. Consistency was defined as match of ADRs and of ADR frequency or match could not be ruled out. Discrepancies were defined as ADRs listed only in one country or listed with different frequencies. We analyzed PIs for 40 separate drugs from ten therapeutic groups and assigned the 4003 identified ADRs to System Organ Classes (Medical Dictionary for Regulatory Activities [MedDRA] terminology). Less than half of listed ADRs (n = 1874; 47%) showed consistency. Discrepancies (n = 2129; 53%) were split into ADRs listed only in the USA (n = 1558; 39%), ADRs listed only in Denmark (n = 325; 8%) and ADRs listed with different frequencies (n = 246; 6%). The majority of listed ADRs were of the type “gastrointestinal disorders” and “nervous system disorders”. Our results show great differences in PIs for drugs approved in both Denmark and the USA illuminating concerns about the credibility of the publicly available PIs. The results also represent an argument for further harmonization across borders to improve consistency between authority-supplied information.

U2 - 10.1002/prp2.38

DO - 10.1002/prp2.38

M3 - Journal article

C2 - 25505588

VL - 2

SP - 1

EP - 10

JO - Pharmacology Research & Perspectives

JF - Pharmacology Research & Perspectives

SN - 2052-1707

IS - 3

M1 - e00038

ER -

ID: 113615912