4 NEWS
ARE YOUR PATIENTS STILL WAITING FOR ASTHMA CONTROL ?* * TRELEGY ELLIPTA IS INDICATED FOR MAINTENANCE TREATMENT OF ASTHMA IN ADULT PATIENTS NOT ADEQUATELY CONTROLLED ON ICS / LABA 1
Trelegy Ellipta showed superior improvement in lung function ( trough
FEV 1
) vs FF / VI ( ICS / LABA ) * 3
4 NEWS
12 JULY 2024 ausdoc . com . au
GP investigated : ‘ I never met the patient ’
FROM PAGE 1 same clinic for 20 years , and I had never worked anywhere else , but when I looked through my computer notes I could not find this patient .
But as anyone who has been faced with a complaint probably knows , you get paranoid ; you assume you have done something wrong . Because we changed to electronic records over 15 years ago , the practice manager went to the storage facility to check the paper records in case the dates in the complaint were wrong .
The practice manager could not find the patient either . To be double sure , I also had a look and failed to find any information about them .
I called the AHPRA investigator , who advised me to state I had never
treated the patient in my response to the complaint .
Then he really threw me .
You assume you ’ ve done something wrong .
He said , “ It would not be a bad idea for you to write something along the lines
ARE YOUR PATIENTS STILL WAITING FOR ASTHMA CONTROL ?* * TRELEGY ELLIPTA IS INDICATED FOR MAINTENANCE TREATMENT OF ASTHMA IN ADULT PATIENTS NOT ADEQUATELY CONTROLLED ON ICS / LABA 1
200 fluticasone furoate / umeclidinium / vilanterol PBS LISTED FOR SEVERE ASTHMA 2
Trelegy Ellipta showed superior improvement in lung function ( trough
FEV 1
) vs FF / VI ( ICS / LABA ) * 3
* Change in trough FEV 1 at 24 weeks ( primary endpoint ): Trelegy Ellipta 200 / 62.5 / 25mcg vs FF / VI 200 / 25mcg 92mL ( 95 % CI 49,135 ), p < 0.0001 ; Trelegy Ellipta 100 / 62.5 / 25mcg vs FF / VI 100 / 25 mcg 110mL ( 95 % CI 66 , 153 ), p < 0.0001 . 3
TRELEGY Ellipta is generally well tolerated . The most commonly reported adverse events were nasopharyngitis , headache and upper respiratory tract infection . 1 , 3 TRELEGY Ellipta 200 PBS listed for severe Asthma 2
Trelegy Ellipta 100 is indicated but not PBS listed for asthma . 1 , 2 FF 100mcg is medium dose and FF 200mcg is high dose ICS . 4
Study design : The CAPTAIN study was a 24-to-52 week , randomised , double-blind , active-controlled , parallel-group , study that evaluated efficacy and safety of TRELEGY Ellipta vs FF / VI in 2436 adult patients whose asthma was inadequately controlled while receiving ICS / LABA . The primary endpoint was mean change from baseline in trough FEV 1 at week 24 . The key secondary endpoint was annualised rate of moderate / severe exacerbations
FEV 1
, forced expiratory volume : FF , fluticasone fuorate ,: ICS , inhaled corticosteroid ; LABA , long-acting beta 2
-agonist : PBS : pharmaceutical benefit scheme :
VI , vilanterol
References : 1 . TRELEGY Ellipta Approved Product Information 2 . www . pbs . gov . au ( accessed on 18th April 2023 ) 3 . Lee et al . Lancet Respir Med 2021 ; 9 : 69-84 4 . National Asthma Council Australia . Australian Asthma Handbook . National Asthma Council Australia , Melbourne , 2023
For more information on GKS products or to report an adverse event involving a GSK product , please contact GSK Medical Information on 1800 033 109 . GlaxoSmithKline Australia Pty Ltd ABN 47 100 162 481 , Melbourne , VIC . Trelegy Ellipta Trade marks are owned by or licensed to the GSK group of companies © 2023 GSK group of companies or its licensor . PM-AU-FVU-ADVT-230002 ( Date of approval : April 2023 )
of how you would treat chronic back pain .”
I responded that whole books had been written on back pain .
I contacted my medical defence organisation and spoke to a lawyer . She agreed that I should send a response saying I had never seen this person before .
As for explaining how I would treat back pain , she said , “ Absolutely no way .”
I sent my response the next day .
It was more than two months later on 17 October 2022 that I got a reply to say the board had decided to take no further action .
The letter came across as cold .
I dealt with the complaint okay , but I have to admit that , in those two months , I probably practised very defensively .
PLEASE REVIEW PRODUCT INFORMATION BEFORE PRESCRIBING
Contraindications : Severe milk-protein allergy or hypersensitivity to any of the ingredients . Pregnancy : Category B3 . Dosage : One inhalation once daily . After inhalation , rinse mouth with water without swallowing .
You cannot help but worry .
I would have loved to have taken time off , but we were so busy . I was dealing with a lot of patient mental health issues .
There was no explanation from AHPRA as to how the complaint came about or whether it was a case of mistaken identity .
I did not call the AHPRA investigator to try to find out how I became involved with a complaint from a patient I had never seen — frankly , I just wanted to put it behind me .
I am only speaking now because I want AHPRA to change .
Yes , we need a regulator , but AHPRA should have crosschecked that I was working at that clinic
There was no explanation as to how it came about .
and made sure I had seen the patient .
It took half a day to find they were not a patient of my clinic . The complaint should not have come across my desk .
Doctors are told that one-third to half of us will face an AHPRA complaint or get sued .
But you think it is never going to happen to you .
When it does , you cannot go back ; your perception is changed for good .
Mine was the best-case scenario in terms of receiving a complaint : it was cut and dried , not ‘ he said ’ and ‘ she said ’. I consider myself lucky . However , it cannot help but change you . It makes you question your commitment to the profession . You go into victim mode .
We are all vulnerable , but if someone is feeling particularly vulnerable when they receive a complaint , it could push them out of the profession .
If I were the patient and AHPRA said , “ This doctor was never involved in your care ,” I would have said , “ Please send my deepest apologies .”
Maybe AHPRA decided not to do that to avoid re-traumatising me .
I guess I will never know .
PBS Information : Severe asthma ( 200 / 62.5 / 25 mcg presentation only ); Authority Required ( Streamlined ). Criteria apply . Refer to PBS for full information .
Footnote : The GP said AHPRA recently contacted her to discuss the case and seemed committed to improving its handling of such complaints .