A modified prescription-event monitoring study to assess the introduction of Flixotide Evohaler into general practice in England: an example of pharmacovigilance planning and risk monitoring.
BACKGROUND
A modified prescription-event monitoring (PEM) study was conducted to examine the safety of the introduction of the metered dose inhaler (MDI) Flixotide Evohaler (fluticasone with the propellant HFA 134a).


METHODS
Patients were identified from the first NHS prescriptions dispensed in England for Flixotide Evohaler. Postal questionnaires were sent to the prescribing doctor, requesting information including: demographic characteristics, severity of indication, concomitant medication, event data 3 months prior to and 3 months after the first prescription, and any reasons for stopping Flixotide. Pregnancies, deaths and selected events were followed up. Incidence density ratios (IDRs) were calculated to compare event rates 3 months before and 3 months after the introduction of Flixotide Evohaler.


RESULTS
The cohort comprised 13 413 patients that were prescribed Flixotide Evohaler. The response rate was 64.0%. When the pre- and post-exposure periods were compared fewer patients had events in the post-exposure period, and there was no significant difference in the length of courses of oral steroid use. Eighteen patients experienced an event within 1 hour of using Flixotide Evohaler; these were minor with the exception of one case of angioneurotic facial oedema. Six of these events were assessed as possibly related to Flixotide Evohaler. During the study period there were an additional 13 patients with events assessed as possibly related to Flixotide Evohaler, including two reports of allergic reactions.


CONCLUSIONS
The results suggest that the transition to Flixotide Evohaler was generally well tolerated. The modified methodology has contributed to the risk management of the introduction of this product.
Perrio
Michael J
MJ
Drug Safety Research Unit, Southampton, UK. michael.perrio@dsru.org
Wilton
Lynda V
LV
Shakir
Saad A W
SA
D016907:Adverse Drug Reaction Reporting Systems / Q000706:statistics & numerical data; D000368:Aged; D000730:Androstadienes / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D015331:Cohort Studies; D004305:Dose-Response Relationship, Drug; D016903:Drug Monitoring / Q000379:methods*; D004739:England; D005194:Family Practice / Q000706:statistics & numerical data*; D005260:Female; D000068298:Fluticasone; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D011247:Pregnancy; D012307:Risk Factors; D011795:Surveys and Questionnaires; D013997:Time Factors
D000730:Androstadienes; D001993:Bronchodilator Agents; D000068298:Fluticasone