Abstract
Purpose: Knowledge on unintended consequences of product withdrawals is limited. Fusafungine, indicated for treatment of upper respiratory airways disease (URAD), was withdrawn in the EU on May 28, 2016. Given concerns about possible substitution with antibiotics, this study aimed to assess the impact of the withdrawal of fusafungine on prescribing of antibiotics and other treatments. Methods: The study was conducted using data from general practitioner (GP) and ear, nose and throat (ENT) practices in IMS® Disease Analyzer Germany. The quarterly prevalence of fusafungine prescribing was analysed for consultations involving the most common URAD between May 29, 2013 and May 28, 2017 in regular fusafungine-prescribing practices. Trends in the quarterly prevalence of antibiotics (AB), other nasal or throat preparations (N&T) and tyrothricin were analyzed. Practices with no fusafungine prescribing during the study served as controls. Changes in prescribing trend were evaluated using interrupted time series regression analysis. Results: In fusafungine-prescribing practices, withdrawal of fusafungine was associated with an immediate increase in prescribing of other N&Ts among patients consulting for URAD (+ 6.4%, 95% CI 2.3–10.5% in GP practices and + 9.0%, 95% CI 5.5–12.5% in ENT practices). There was no increase in antibiotic prescribing. In ENT practices; a small transient increase in tyrothricin prescribing occurred. No changes were seen in non-fusafungine-prescribing practices. Conclusions: Withdrawal of fusafungine was not associated with increased prescribing of antibiotics but was associated with increased prescribing of other N&Ts. The unintended impact of substitution to other treatments should be considered routinely when products are withdrawn or restricted in other ways.
| Original language | English |
|---|---|
| Pages (from-to) | 979-984 |
| Number of pages | 6 |
| Journal | European Journal of Clinical Pharmacology |
| Volume | 75 |
| Issue number | 7 |
| Early online date | 5 Mar 2019 |
| DOIs | |
| Publication status | Published - Jul 2019 |
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Keywords
- Alternative prescribing
- Antibiotics
- Fusafungine
- Upper respiratory airways disease
Cite this
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Effect of withdrawal of fusafungine from the market on prescribing of antibiotics and other alternative treatments in Germany : a pharmacovigilance impact study. / Hedenmalm, Karin; Kurz, Xavier; Morales, Daniel.
In: European Journal of Clinical Pharmacology, Vol. 75, No. 7, 07.2019, p. 979-984.Research output: Contribution to journal › Article
TY - JOUR
T1 - Effect of withdrawal of fusafungine from the market on prescribing of antibiotics and other alternative treatments in Germany
T2 - a pharmacovigilance impact study
AU - Hedenmalm, Karin
AU - Kurz, Xavier
AU - Morales, Daniel
PY - 2019/7
Y1 - 2019/7
N2 - Purpose: Knowledge on unintended consequences of product withdrawals is limited. Fusafungine, indicated for treatment of upper respiratory airways disease (URAD), was withdrawn in the EU on May 28, 2016. Given concerns about possible substitution with antibiotics, this study aimed to assess the impact of the withdrawal of fusafungine on prescribing of antibiotics and other treatments. Methods: The study was conducted using data from general practitioner (GP) and ear, nose and throat (ENT) practices in IMS® Disease Analyzer Germany. The quarterly prevalence of fusafungine prescribing was analysed for consultations involving the most common URAD between May 29, 2013 and May 28, 2017 in regular fusafungine-prescribing practices. Trends in the quarterly prevalence of antibiotics (AB), other nasal or throat preparations (N&T) and tyrothricin were analyzed. Practices with no fusafungine prescribing during the study served as controls. Changes in prescribing trend were evaluated using interrupted time series regression analysis. Results: In fusafungine-prescribing practices, withdrawal of fusafungine was associated with an immediate increase in prescribing of other N&Ts among patients consulting for URAD (+ 6.4%, 95% CI 2.3–10.5% in GP practices and + 9.0%, 95% CI 5.5–12.5% in ENT practices). There was no increase in antibiotic prescribing. In ENT practices; a small transient increase in tyrothricin prescribing occurred. No changes were seen in non-fusafungine-prescribing practices. Conclusions: Withdrawal of fusafungine was not associated with increased prescribing of antibiotics but was associated with increased prescribing of other N&Ts. The unintended impact of substitution to other treatments should be considered routinely when products are withdrawn or restricted in other ways.
AB - Purpose: Knowledge on unintended consequences of product withdrawals is limited. Fusafungine, indicated for treatment of upper respiratory airways disease (URAD), was withdrawn in the EU on May 28, 2016. Given concerns about possible substitution with antibiotics, this study aimed to assess the impact of the withdrawal of fusafungine on prescribing of antibiotics and other treatments. Methods: The study was conducted using data from general practitioner (GP) and ear, nose and throat (ENT) practices in IMS® Disease Analyzer Germany. The quarterly prevalence of fusafungine prescribing was analysed for consultations involving the most common URAD between May 29, 2013 and May 28, 2017 in regular fusafungine-prescribing practices. Trends in the quarterly prevalence of antibiotics (AB), other nasal or throat preparations (N&T) and tyrothricin were analyzed. Practices with no fusafungine prescribing during the study served as controls. Changes in prescribing trend were evaluated using interrupted time series regression analysis. Results: In fusafungine-prescribing practices, withdrawal of fusafungine was associated with an immediate increase in prescribing of other N&Ts among patients consulting for URAD (+ 6.4%, 95% CI 2.3–10.5% in GP practices and + 9.0%, 95% CI 5.5–12.5% in ENT practices). There was no increase in antibiotic prescribing. In ENT practices; a small transient increase in tyrothricin prescribing occurred. No changes were seen in non-fusafungine-prescribing practices. Conclusions: Withdrawal of fusafungine was not associated with increased prescribing of antibiotics but was associated with increased prescribing of other N&Ts. The unintended impact of substitution to other treatments should be considered routinely when products are withdrawn or restricted in other ways.
KW - Alternative prescribing
KW - Antibiotics
KW - Fusafungine
KW - Upper respiratory airways disease
UR - http://www.scopus.com/inward/record.url?scp=85062694145&partnerID=8YFLogxK
U2 - 10.1007/s00228-019-02650-z
DO - 10.1007/s00228-019-02650-z
M3 - Article
VL - 75
SP - 979
EP - 984
JO - European Journal of Clinical Pharmacology
JF - European Journal of Clinical Pharmacology
SN - 0031-6970
IS - 7
ER -