Case study: COPD medicine (Braltus) and choking

Background information

A woman in her sixties was taking Braltus COPD. Braltus is prescribed in the form of a powder within a hard pill capsule and is taken using a Zonda inhaler. 

A pharmacy assistant sent a Yellow Card report for a woman. She had inserted the capsule into the mouthpiece of the inhaler by mistake which was sucked into her throat. The patient coughed the capsule out but this could have choked her. The assistant included in the Yellow Card report that the design of the inhaler allowed the capsule to be incorrectly placed into the mouthpiece. This could be a choking risk for patients. The Medicines and Healthcare products Regulatory Agency (MHRA) also received an enquiry from Medication Safety Officer (MSO), a hospital pharmacist regarding this problem, after inspecting the device before prescribing. 

Investigation

After receiving the reports, a detailed review of the safety information was done by the MHRA scientific assessor. This often includes contacting the Defective Medicines Report Centre (DMRC) to see if any similar safety data has been received. DMRC said that a practice nurse demonstrating the same Braltus Zonda inhaler to an elderly patient saw a similar mistake occur. The nurse raised the concern that this could lead to choking. 

Response

Safety signals that contain a medicine and a device are considered by the MHRA Drug Device Combination (DDC) expert group. The DDC expert group met with the manufacturer and recommended changes to the instructions for use, including new pictures showing the correct way to insert a capsule into the inhaler. 

A new warning was also added about the risk of choking and advice that capsules should never be placed directly into the mouthpiece of the inhaler. Similar information was added inside the packaging lid. A Drug Safety Update (DSU) article was issued by the MHRA to inform healthcare professionals of the safety issue. The DSU is our monthly bulletin to inform healthcare professionals of the latest issues in medicines safety. 

Additional information

Chronic obstructive pulmonary disease (COPD):

COPD is the name for a group of lung conditions that cause breathing difficulties. It is used to describe progressive lung diseases such as emphysema, chronic bronchitis, and non-reversible asthma.

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