The Department of Health (DH) today (July 27) alerted healthcare professionals and the public of a potential malfunction of the delivery device of Pulmicort Turbuhaler 200 µg per metered dose.
Through its surveillance network, DH noted from the announcement of Health Canada that marketing authorisation holder AstraZeneca Canada Inc (AstraZeneca) has received a small number of product complaints for Pulmicort Turbuhaler 200 µg per metered dose regarding the malfunction of the delivery device that results in a failure to dispense the dose of medication.
According to the information from AstraZeneca, the cause of the complaints is related to an issue within the dosing unit and this affects the Pulmicort Turbuhaler 200 µg per metered dose. The patient will not hear the "click" sound when the "turn grip" is rotated, and the intended dose of medication will not be loaded into the unit. Patients who do not realise that the dose has not been loaded may go for a period of time without receiving the prescribed treatment. AstraZeneca is investigating the source of the problem.
DH's investigation continues. DH has already contacted Health Canada and AstraZeneca for their assessment of the incident.
So far DH has not received any adverse event reports concerning the product.
Pulmicort Turbuhaler 200 µg per metered dose (100 doses and 200 doses) (Registration number: HK-33965) is a prescription drug registered by AstraZeneca Hong Kong Ltd. It can only be sold on doctor's prescription under the supervision of pharmacists in registered pharmacies.
Pulmicort Turbuhaler contains budesonide which is a glucocorticosteroid for the treatment of bronchial asthma.
"Patients using the product should listen to the 'click' sound, as an indication that the inhaler has been loaded and is ready to use. If they are in doubt or they suspect that the device is not working properly, they should seek advice from healthcare professionals.
"Healthcare professionals should reinforce the proper use of the Pulmicort Turbuhaler device with patients (TURN, CLICK, INHALE) and remind their patients the importance of listening to the 'click' sound," DH spokesman said.
DH will issue letter to inform healthcare professionals and relevant associations of the above incident.
AstraZeneca Hong Kong Ltd has set up a hotline (3752 4290) for public enquiries.
Reprinted from HKSAR Government web page:
http://www.info.gov.hk/gia/general/201207/27/P201207270627.htm