By Suzanne Hodsden
GlaxoSmithKline (GSK) has received concerns from health professionals that the color of their Revlar Ellipta inhaler might be misleading to patients and announced today that in in future, they would be manufacturing the inhaler as yellow rather than blue and providing additional information in the labeling, The Pharmaceutical Journal (TPJ) reports.
In February, doctors issued a statement to both pharmacists and GSK warning them about possible dosing errors that could occur as a result of the current packaging.
Healthcare workers are concerned that patients might inadvertently believe that Revlar Ellipta is meant to be used during an attack rather than as a once-a-day preventative measure.
The statement explained, “For many years, pharmacists and other healthcare professionals have been educating patients on when to use their inhalers for asthma and COPD, and frequently use simple terms such as “reliever” or “blue inhaler” to advise patients when to use their salbutamol or terbutaline, and terms such as “preventer” or “brown, red, or purple inhaler” to advise patients when to used their inhaled corticosteroid inhaler.”
Toby Capstick, co-author of the statement and respiratory pharmacist at Leeds teaching Hospital, told TPJ, “GSK has taken this on board, though patient safety could be an issue in the U.K. and has done something about it.”
In addition to the color, GSK announced that they were making changes to the labeling, improving legibility of the wording and adding colored logos to indicate the strength of the inhaler and a space for patients to make note of when the inhaler needs to be thrown out.
A representative from GSK notified Outsourced Pharma that the packaging of Relvar Ellipta will only change in European countries, in response to feedback received from doctors & pharmacists specific to the terminology used in clinical practice in the UK. According to the source, "The colour and packaging of Relvar Ellipta will remain the same in other countries including the US."
Last year, the FDA launched an investigation into the role of color in patient understanding and regimen adherence and issued a non-binding guidance about the possible adverse effects that occur as a result of appearance changes.
According to the FDA, “Studies indicate that patients are more likely to stop taking their medications when they experience a change in their drugs’ physical appearances, leading to harmful clinical and public health consequences.”
Representatives from GSK have already anticipated this concern.
Hamzah Baig, respiratory medical director at GSK, told TPJ, “We will be working very closely with pharmacists to make sure that the change itself does not cause confusion for patients. Pharmacists should be seeing a lot of communication from us to help them make the change for patients who are already on blue Revlar to move over to yellow.”
GSK stated that the new yellow inhalers should be available early next year.