TY - JOUR
T1 - Influence of drug safety advisories on drug utilisation
T2 - an international interrupted time series and meta-analysis
AU - Morrow, Richard L.
AU - Mintzes, Barbara
AU - Souverein, Patrick C.
AU - De Bruin, Marie L.
AU - Roughead, Elizabeth Ellen
AU - Lexchin, Joel
AU - Kemp-Casey, Anna
AU - Puil, Lorri
AU - Sketris, Ingrid
AU - Mangin, Dee
AU - Hallgreen, Christine E.
AU - Pearson, Sallie-Anne
AU - Lopert, Ruth
AU - Bero, Lisa
AU - Ofori-Asenso, Richard
AU - Gnjidic, Danijela
AU - Sarpatwari, Ameet
AU - Perry, Lucy T.
AU - Dormuth, Colin R.
PY - 2022
Y1 - 2022
N2 - Objective To evaluate the association between regulatory drug safety advisories and changes in drug utilisation. Design We conducted controlled, interrupted times series analyses with administrative prescription claims data to estimate changes in drug utilisation following advisories. We used random-effects meta-analysis with inverse-variance weighting to estimate the average postadvisory change in drug utilisation across advisories. Study population We included advisories issued in Canada, Denmark, the UK and the USA during 2009-2015, mainly concerning drugs in common use in primary care. We excluded advisories related to over-the-counter drugs, drug-drug interactions, vaccines, drugs used primarily in hospital and advisories with co-interventions within +/- 6 months. Main outcome measures Change in drug utilisation, defined as actual versus predicted percentage change in the number of prescriptions (for advisories without dose-related advice), or in the number of defined daily doses (for dose-related advisories), per 100 000 population. Results Among advisories without dose-related advice (n=20), the average change in drug utilisation was -5.83% (95% CI -10.93 to -0.73; p=0.03). Advisories with dose-related advice (n=4) were not associated with a statistically significant change in drug utilisation (-1.93%; 95% CI -17.10 to 13.23; p=0.80). In a post hoc subgroup analysis of advisories without dose-related advice, we observed no statistically significant difference between the change in drug utilisation following advisories with explicit prescribing advice, such as a recommendation to consider the risk of a drug when prescribing, and the change in drug utilisation following advisories without such advice. Conclusions Among safety advisories issued on a wide range of drugs during 2009-2015 in 4 countries (Canada, Denmark, the UK and the USA), the association of advisories with changes in drug utilisation was variable, and the average association was modest.
AB - Objective To evaluate the association between regulatory drug safety advisories and changes in drug utilisation. Design We conducted controlled, interrupted times series analyses with administrative prescription claims data to estimate changes in drug utilisation following advisories. We used random-effects meta-analysis with inverse-variance weighting to estimate the average postadvisory change in drug utilisation across advisories. Study population We included advisories issued in Canada, Denmark, the UK and the USA during 2009-2015, mainly concerning drugs in common use in primary care. We excluded advisories related to over-the-counter drugs, drug-drug interactions, vaccines, drugs used primarily in hospital and advisories with co-interventions within +/- 6 months. Main outcome measures Change in drug utilisation, defined as actual versus predicted percentage change in the number of prescriptions (for advisories without dose-related advice), or in the number of defined daily doses (for dose-related advisories), per 100 000 population. Results Among advisories without dose-related advice (n=20), the average change in drug utilisation was -5.83% (95% CI -10.93 to -0.73; p=0.03). Advisories with dose-related advice (n=4) were not associated with a statistically significant change in drug utilisation (-1.93%; 95% CI -17.10 to 13.23; p=0.80). In a post hoc subgroup analysis of advisories without dose-related advice, we observed no statistically significant difference between the change in drug utilisation following advisories with explicit prescribing advice, such as a recommendation to consider the risk of a drug when prescribing, and the change in drug utilisation following advisories without such advice. Conclusions Among safety advisories issued on a wide range of drugs during 2009-2015 in 4 countries (Canada, Denmark, the UK and the USA), the association of advisories with changes in drug utilisation was variable, and the average association was modest.
KW - health policy
KW - health services research
KW - medication safety
KW - pharmacoepidemiology
U2 - 10.1136/bmjqs-2021-013910
DO - 10.1136/bmjqs-2021-013910
M3 - Journal article
C2 - 35058332
VL - 31
SP - 179
EP - 190
JO - BMJ Quality and Safety
JF - BMJ Quality and Safety
SN - 2044-5415
IS - 3
ER -