About you
3. Which best describes your response?
Please select one item
Radio button:
Unticked
I am responding as an individual (proceed to question 5)
Radio button:
Ticked
I am responding on behalf of an organisation
1. Increasing awareness and understanding
1. Did you know where to find guidance or information on recalls prior to this survey?
Did you know where to find guidance or information on recalls prior to this survey
Yes
2. Do you have any feedback on our current recall guidance in the URPTG or on our website? What do you like about it? How could it improve?
Feedback
The actual link to the URPTG is buried too far down the page. It needs to be more prominent and easy to locate. For immediate recalls (step 1) details need to be readily located. Information such as changes to versions, is a nice to have but it doesn't need to be in such a prominent position.
Details and directions need to be short, sharp and concise. It is nice to include 'please' but for these actions it's just added, fluffy language that doesn't need to be there.
Details and directions need to be short, sharp and concise. It is nice to include 'please' but for these actions it's just added, fluffy language that doesn't need to be there.
3. What do you think are the best recommendations from the dropdown list? Please pick your top three preferences in order of 1st, 2nd, and 3rd.
1st preference (i.e. the best recommendation)
Please select one item
Radio button:
Unticked
updating our guidance to include more general advice for sponsors
Radio button:
Ticked
developing educational sessions about recalls for sponsors – e.g. ‘how to undertake an effective recall’
Radio button:
Unticked
workshops or seminars for health professionals on how to effectively respond to a recall
Radio button:
Unticked
creating more general awareness and educational material for consumers
Radio button:
Unticked
better use of the TGA social media channels, including campaign-based messaging
Radio button:
Unticked
upgrading our public information recall database (SARA) to make it more searchable, user-friendly and modern
Radio button:
Unticked
including more visual content with our recall alerts
Radio button:
Unticked
having targeted information for different stakeholder groups for significant recalls
Radio button:
Unticked
including Unique Identifiers in recall information (where and when they become available)
2nd preference
Please select one item
Radio button:
Unticked
updating our guidance to include more general advice for sponsors
Radio button:
Unticked
developing educational sessions about recalls for sponsors – e.g. ‘how to undertake an effective recall’
Radio button:
Unticked
workshops or seminars for health professionals on how to effectively respond to a recall
Radio button:
Unticked
creating more general awareness and educational material for consumers
Radio button:
Ticked
better use of the TGA social media channels, including campaign-based messaging
Radio button:
Unticked
upgrading our public information recall database (SARA) to make it more searchable, user-friendly and modern
Radio button:
Unticked
including more visual content with our recall alerts
Radio button:
Unticked
having targeted information for different stakeholder groups for significant recalls
Radio button:
Unticked
including Unique Identifiers in recall information (where and when they become available)
3rd preference
Please select one item
Radio button:
Unticked
updating our guidance to include more general advice for sponsors
Radio button:
Unticked
developing educational sessions about recalls for sponsors – e.g. ‘how to undertake an effective recall’
Radio button:
Unticked
workshops or seminars for health professionals on how to effectively respond to a recall
Radio button:
Unticked
creating more general awareness and educational material for consumers
Radio button:
Unticked
better use of the TGA social media channels, including campaign-based messaging
Radio button:
Unticked
upgrading our public information recall database (SARA) to make it more searchable, user-friendly and modern
Radio button:
Ticked
including more visual content with our recall alerts
Radio button:
Unticked
having targeted information for different stakeholder groups for significant recalls
Radio button:
Unticked
including Unique Identifiers in recall information (where and when they become available)
4. Do you have any other suggestions or strategies to improve our guidance and increase awareness of recalls?
Any other suggestions
I have a food background and FSANZ already have a good model implemented.
It is mandatory that ALL food businesses have a recall procedure and they should have someone on site who has undertaken recall training. It is also mandatory (through certification standards) that the recall system is tested annually via mock recalls. This enables personnel and systems to test their capability to track and trace product in a timely manner.
It is mandatory that ALL food businesses have a recall procedure and they should have someone on site who has undertaken recall training. It is also mandatory (through certification standards) that the recall system is tested annually via mock recalls. This enables personnel and systems to test their capability to track and trace product in a timely manner.
2 a. Who we contact and consult with, before the sponsor starts a recall
1. Do you see any benefits if we communicate more with different stakeholders, such as patient advocacy groups and professional bodies, before commencing a recall?
Please select one item
Radio button:
Unticked
Yes
Radio button:
Ticked
No
If yes, why do you think this is important? If no, what are your concerns and are there situations when we should not consult before commencing a recall?
The more parties involved at this stage of a recall, the more chance of a delay in making a decision and implementing the recall.
It would be a better strategy to have the pathways (specific communications/ processes etc) documented for the specific stakeholder groups and directly implemented once the details of a potential recall are known.
It would be a better strategy to have the pathways (specific communications/ processes etc) documented for the specific stakeholder groups and directly implemented once the details of a potential recall are known.
2. Are there other questions we should be asking in our urgent notification of a potential recall?
Are there other questions we should be asking in our urgent notification of a potential recall?
??
2 b. How information is distributed
1. If you have seen any recall communication material, what did you think? Could you rate it on the following aspects?
| Was it easy to find? Very bad Radio button: Not checked Very bad | Was it easy to find? Bad Radio button: Not checked Bad | Was it easy to find? Ok Radio button: Not checked Ok | Was it easy to find? Good Radio button: Checked Good | Was it easy to find? Very good Radio button: Not checked Very good |
| Easy to read? Very bad Radio button: Not checked Very bad | Easy to read? Bad Radio button: Checked Bad | Easy to read? Ok Radio button: Not checked Ok | Easy to read? Good Radio button: Not checked Good | Easy to read? Very good Radio button: Not checked Very good |
| Was the key message clear? Very bad Radio button: Not checked Very bad | Was the key message clear? Bad Radio button: Checked Bad | Was the key message clear? Ok Radio button: Not checked Ok | Was the key message clear? Good Radio button: Not checked Good | Was the key message clear? Very good Radio button: Not checked Very good |
| Did it explain how to get more information? Very bad Radio button: Not checked Very bad | Did it explain how to get more information? Bad Radio button: Not checked Bad | Did it explain how to get more information? Ok Radio button: Checked Ok | Did it explain how to get more information? Good Radio button: Not checked Good | Did it explain how to get more information? Very good Radio button: Not checked Very good |
2. What do you think are the best options from the below list to improve our communications? Could you please rank them in order of most beneficial (1st) to the lowest benefit (6th).
| Increase our communication channels, including asking relevant partner organisations such as patient advocacy groups to send out information using their established networks 1st (most beneficial) Radio button: Not checked 1st (most beneficial) | Increase our communication channels, including asking relevant partner organisations such as patient advocacy groups to send out information using their established networks 2nd Radio button: Not checked 2nd | Increase our communication channels, including asking relevant partner organisations such as patient advocacy groups to send out information using their established networks 3rd Radio button: Not checked 3rd | Increase our communication channels, including asking relevant partner organisations such as patient advocacy groups to send out information using their established networks 4th Radio button: Checked 4th | Increase our communication channels, including asking relevant partner organisations such as patient advocacy groups to send out information using their established networks 5th Radio button: Not checked 5th | Increase our communication channels, including asking relevant partner organisations such as patient advocacy groups to send out information using their established networks 6th (lowest benefit) Radio button: Not checked 6th (lowest benefit) |
| Better and more targeted use of social media 1st (most beneficial) Radio button: Checked 1st (most beneficial) | Better and more targeted use of social media 2nd Radio button: Not checked 2nd | Better and more targeted use of social media 3rd Radio button: Not checked 3rd | Better and more targeted use of social media 4th Radio button: Not checked 4th | Better and more targeted use of social media 5th Radio button: Not checked 5th | Better and more targeted use of social media 6th (lowest benefit) Radio button: Not checked 6th (lowest benefit) |
| Use existing third-party communication networks, such as patient newsletters and private broadcast channels 1st (most beneficial) Radio button: Not checked 1st (most beneficial) | Use existing third-party communication networks, such as patient newsletters and private broadcast channels 2nd Radio button: Not checked 2nd | Use existing third-party communication networks, such as patient newsletters and private broadcast channels 3rd Radio button: Not checked 3rd | Use existing third-party communication networks, such as patient newsletters and private broadcast channels 4th Radio button: Not checked 4th | Use existing third-party communication networks, such as patient newsletters and private broadcast channels 5th Radio button: Checked 5th | Use existing third-party communication networks, such as patient newsletters and private broadcast channels 6th (lowest benefit) Radio button: Not checked 6th (lowest benefit) |
| Improving our website subscription service to allow automated emails/text message alerts for certain types of recalls 1st (most beneficial) Radio button: Not checked 1st (most beneficial) | Improving our website subscription service to allow automated emails/text message alerts for certain types of recalls 2nd Radio button: Checked 2nd | Improving our website subscription service to allow automated emails/text message alerts for certain types of recalls 3rd Radio button: Not checked 3rd | Improving our website subscription service to allow automated emails/text message alerts for certain types of recalls 4th Radio button: Not checked 4th | Improving our website subscription service to allow automated emails/text message alerts for certain types of recalls 5th Radio button: Not checked 5th | Improving our website subscription service to allow automated emails/text message alerts for certain types of recalls 6th (lowest benefit) Radio button: Not checked 6th (lowest benefit) |
| Asking retailers to display the recall notice in their shopfront 1st (most beneficial) Radio button: Not checked 1st (most beneficial) | Asking retailers to display the recall notice in their shopfront 2nd Radio button: Not checked 2nd | Asking retailers to display the recall notice in their shopfront 3rd Radio button: Checked 3rd | Asking retailers to display the recall notice in their shopfront 4th Radio button: Not checked 4th | Asking retailers to display the recall notice in their shopfront 5th Radio button: Not checked 5th | Asking retailers to display the recall notice in their shopfront 6th (lowest benefit) Radio button: Not checked 6th (lowest benefit) |
| Better outreach to groups representing vulnerable consumers, such as culturally and linguistically diverse (CALD) consumers, First Nations consumers, older consumers and consumers with a disability. 1st (most beneficial) Radio button: Not checked 1st (most beneficial) | Better outreach to groups representing vulnerable consumers, such as culturally and linguistically diverse (CALD) consumers, First Nations consumers, older consumers and consumers with a disability. 2nd Radio button: Not checked 2nd | Better outreach to groups representing vulnerable consumers, such as culturally and linguistically diverse (CALD) consumers, First Nations consumers, older consumers and consumers with a disability. 3rd Radio button: Not checked 3rd | Better outreach to groups representing vulnerable consumers, such as culturally and linguistically diverse (CALD) consumers, First Nations consumers, older consumers and consumers with a disability. 4th Radio button: Not checked 4th | Better outreach to groups representing vulnerable consumers, such as culturally and linguistically diverse (CALD) consumers, First Nations consumers, older consumers and consumers with a disability. 5th Radio button: Not checked 5th | Better outreach to groups representing vulnerable consumers, such as culturally and linguistically diverse (CALD) consumers, First Nations consumers, older consumers and consumers with a disability. 6th (lowest benefit) Radio button: Checked 6th (lowest benefit) |
3. Please give us any other suggestions you have. What other communication methods could we use to increase the distribution of recall information?
Please give us any other suggestions you have. What other communication methods could we use to increase the distribution of recall information?
Do not underestimate the power of social media. It is very powerful and can be extremely wide reaching. Mainstream media (print, radio and television) will usually pick up these stories, but these media outlets should also be included in notifications.
Retail outlets should also be made (legally required) to display the recall notices if they are carrying the product.
The notion 'of sending a letter' should be removed from the narrative. The direction should be more of 'advised in writing'. This will allow for a number of communication methods without the need to specify exactly.
Retail outlets should also be made (legally required) to display the recall notices if they are carrying the product.
The notion 'of sending a letter' should be removed from the narrative. The direction should be more of 'advised in writing'. This will allow for a number of communication methods without the need to specify exactly.
2 c. Communicating in complex supply networks
1. Do you regularly receive either the TGA’s recall notices or the recall letters from sponsors? Do you receive the same information from multiple sources?
Do you regularly receive either the TGA’s recall notices or the recall letters from sponsors? Do you receive the same information from multiple sources?
Only TGA Recall notices.
2. If you are part of a supply chain (wholesale, retail, hospital procurement, etc), to whom do you regularly need to pass recall information?
If you are part of a supply chain (wholesale, retail, hospital procurement, etc), to whom do you regularly need to pass recall information?
We issue recall notices to all of our warehouses and our retail outlets to ensure stock is identified, quarantined and returned as appropriate.
3. Are there any known or foreseeable weaknesses in this communication chain?
Are there any known or foreseeable weaknesses in this communication chain?
Not in our process, as we also follow food recalls. We have an established process which is followed for both systems.
4. If you are a stakeholder who needs to track the recalled products, how do you do this effectively?
If you are a stakeholder who needs to track the recalled products, how do you do this effectively?
N/A
5. How could we improve the visibility and transparency of therapeutic goods supply chains? For example, should government require sponsors to have a regulatory obligation to document their supply chain and goods distributed by any subsequent (downstream) supplier?
How could we improve the visibility and transparency of therapeutic goods supply chains? For example, should government require sponsors to have a regulatory obligation to document their supply chain and goods distributed by any subsequent (downstream) supplier?
This would be a nightmare!
It should be the obligation of the manufacturer to know their own customer base. It is their responsibility to notify their customers of a recall. I don't believe this list should or need be supplied to TGA. Part of the recall notification should be to include the S&T Recall Coordinators in their notification, who will then inform potential stakeholders (depending on product). This will allow for wider communication of the issue. It is better to give a more general, widespread message, than focusing on trying to contact every individual consumer.
It should be the obligation of the manufacturer to know their own customer base. It is their responsibility to notify their customers of a recall. I don't believe this list should or need be supplied to TGA. Part of the recall notification should be to include the S&T Recall Coordinators in their notification, who will then inform potential stakeholders (depending on product). This will allow for wider communication of the issue. It is better to give a more general, widespread message, than focusing on trying to contact every individual consumer.
6. Should we have more guidance for retailers, pharmacists or other healthcare providers on how to advise consumers or patients about recalls?
Should we have more guidance for retailers, pharmacists or other healthcare providers on how to advise consumers or patients about recalls?
The standard recall notice should hold all of the information for any player in the supply chain. The message to retailers etc is to display these notices prominently and to advise subsequent actions eg. return of stock / disposal etc.
2 d. The timing of recall notifications
1. Do you think the current timeframe for TGA’s release of recall information is appropriate?
Please select one item
Radio button:
Unticked
Yes
Radio button:
Ticked
No
Radio button:
Unticked
Not sure
2. Do you think TGA should always wait until we have the sponsor’s agreement on the recall before sending any information to other stakeholders?
Do you think TGA should always wait until we have the sponsor’s agreement on the recall before sending any information to other stakeholders?
Recall needs to be agreed by all stakeholders before any notifications are issued.
3. Which of these options do you think is best, and why?
Please select all that apply
Checkbox:
Unticked
Reduce our delay of publicising recall information to one working day after agreement with the sponsor
Checkbox:
Ticked
Distribute and publicise recall information on the same day as the agreement of the recall
Checkbox:
Unticked
Develop and formalise a risked-based approach, where higher risk recalls are publicised within a shorter timeframe
Checkbox:
Unticked
Make no change if the current approach (two working day delay) is felt to be still fit for purpose
What risks do you see with any of the above options?
Once a recall is agreed, the quicker the information is released the better. You can't wait for sponsors to contact their customers first. This will depend on the number of customers, contactibility of customers etc.
GET THE MESSAGE OUT!
GET THE MESSAGE OUT!
2 e. The content of our recall notices
1. If you receive our recall email notifications, what is your feedback on the content in the email and Recall Notice?
If you receive our recall email notifications, what is your feedback on the content?
Too wordy.
In the example above, under Reason, the last 2 sentences are not required.
Again, too much emphasis on 'Supplier letter'. Why does this need to be issued? Once the sponsor notifies TGA and the recall is agreed, details that are entered into SARA should become the one source of the truth, where the TGA recall notice is generated from.
In the example above, under Reason, the last 2 sentences are not required.
Again, too much emphasis on 'Supplier letter'. Why does this need to be issued? Once the sponsor notifies TGA and the recall is agreed, details that are entered into SARA should become the one source of the truth, where the TGA recall notice is generated from.
2. Would providing the sponsor’s customer letter with our email notifications be beneficial? Should we continue to provide our recall summary notice, or just provide the sponsor’s customer letter and a link to the SARA database summary?
Would providing the sponsor’s customer letter with our email notifications be beneficial? Should we continue to provide our recall summary notice, or just provide the sponsor’s customer letter and a link to the SARA database summary?
Sponsor's letter should not be required. Refer above.
3. Do you have any other suggestions to improve our recall communications?
Do you have any other suggestions to improve our recall communications?
As above.
3. Better recall descriptions
1. Do you agree with the new recall descriptions?
Please select one item
Radio button:
Ticked
Yes
Radio button:
Unticked
No
Radio button:
Unticked
Not sure
If yes, what do you like about them? What are the benefits you see?
Much more simplified.
The recall procedure needs to include definitions of all 4 x categories.
The recall procedure needs to include definitions of all 4 x categories.
If no, what are your concerns?
N/A
2. Do you have any other suggestions for new terminology?
Do you have any other suggestions for new terminology?
No.
4. Improving sponsor letters and other recall documents
1. What do you think of our current templates?
Do you have any feedback on the current content or draft wording?
Current templates are too wordy and very outdated.
The new template is much clearer and easier to follow.
Again, I am not convinced 'Letters' and customer acknowledgement is required. This makes the process very cumbersome and admin heavy. If the notification mechanism is held by TGA (eg on website), the questions will be standardised (all sponsors have to answer the same questions), TGA can use standardised data as they will have a database that will allow easy reporting.
Why does the TGA need to have customer acknowledgement? This should all be managed by the sponsor and maybe as simple as a phone confirmation or email.
The new template is much clearer and easier to follow.
Again, I am not convinced 'Letters' and customer acknowledgement is required. This makes the process very cumbersome and admin heavy. If the notification mechanism is held by TGA (eg on website), the questions will be standardised (all sponsors have to answer the same questions), TGA can use standardised data as they will have a database that will allow easy reporting.
Why does the TGA need to have customer acknowledgement? This should all be managed by the sponsor and maybe as simple as a phone confirmation or email.
Do you have any feedback on the presentation/style of the templates?
Much clearer
Are the templates easy to read?
Yes
Will the key message be clear?
Yes
2. If you have received recall letters before, what information did you find most useful? Was there anything important missing, or you struggled to find?
If you have received recall letters before, what information did you find most useful? Was there anything important missing, or you struggled to find?
Not received any
3. What do you think of the suggested options? Please indicate how beneficial you think each change would be.
| Work with sponsors to modernise our templates for customer letters, acknowledgment forms, customer lists and mail envelopes to increase their usage. Very bad Radio button: Checked Very bad | Work with sponsors to modernise our templates for customer letters, acknowledgment forms, customer lists and mail envelopes to increase their usage. Bad Radio button: Not checked Bad | Work with sponsors to modernise our templates for customer letters, acknowledgment forms, customer lists and mail envelopes to increase their usage. Ok Radio button: Not checked Ok | Work with sponsors to modernise our templates for customer letters, acknowledgment forms, customer lists and mail envelopes to increase their usage. Good Radio button: Not checked Good | Work with sponsors to modernise our templates for customer letters, acknowledgment forms, customer lists and mail envelopes to increase their usage. Very good Radio button: Not checked Very good |
| Require sponsors to submit customer list details in a consistent format, including the number of units supplied. Very bad Radio button: Checked Very bad | Require sponsors to submit customer list details in a consistent format, including the number of units supplied. Bad Radio button: Not checked Bad | Require sponsors to submit customer list details in a consistent format, including the number of units supplied. Ok Radio button: Not checked Ok | Require sponsors to submit customer list details in a consistent format, including the number of units supplied. Good Radio button: Not checked Good | Require sponsors to submit customer list details in a consistent format, including the number of units supplied. Very good Radio button: Not checked Very good |
| Require sponsors to use the TGA templates for customer letters, thus standardising recall communications in Australia. Very bad Radio button: Not checked Very bad | Require sponsors to use the TGA templates for customer letters, thus standardising recall communications in Australia. Bad Radio button: Not checked Bad | Require sponsors to use the TGA templates for customer letters, thus standardising recall communications in Australia. Ok Radio button: Checked Ok | Require sponsors to use the TGA templates for customer letters, thus standardising recall communications in Australia. Good Radio button: Not checked Good | Require sponsors to use the TGA templates for customer letters, thus standardising recall communications in Australia. Very good Radio button: Not checked Very good |
| Include on all recall letters the key details of the action (the action category, the hazard classification (class I, class II, etc.) the action level (hospital, retail, etc.). Very bad Radio button: Not checked Very bad | Include on all recall letters the key details of the action (the action category, the hazard classification (class I, class II, etc.) the action level (hospital, retail, etc.). Bad Radio button: Not checked Bad | Include on all recall letters the key details of the action (the action category, the hazard classification (class I, class II, etc.) the action level (hospital, retail, etc.). Ok Radio button: Not checked Ok | Include on all recall letters the key details of the action (the action category, the hazard classification (class I, class II, etc.) the action level (hospital, retail, etc.). Good Radio button: Checked Good | Include on all recall letters the key details of the action (the action category, the hazard classification (class I, class II, etc.) the action level (hospital, retail, etc.). Very good Radio button: Not checked Very good |
| Include greater use of electronic acknowledgement forms (e.g. include a survey link or a QR code and that can be easily operated by the customer’s mobile). Very bad Radio button: Not checked Very bad | Include greater use of electronic acknowledgement forms (e.g. include a survey link or a QR code and that can be easily operated by the customer’s mobile). Bad Radio button: Not checked Bad | Include greater use of electronic acknowledgement forms (e.g. include a survey link or a QR code and that can be easily operated by the customer’s mobile). Ok Radio button: Not checked Ok | Include greater use of electronic acknowledgement forms (e.g. include a survey link or a QR code and that can be easily operated by the customer’s mobile). Good Radio button: Not checked Good | Include greater use of electronic acknowledgement forms (e.g. include a survey link or a QR code and that can be easily operated by the customer’s mobile). Very good Radio button: Checked Very good |
If you ticked any options as bad, what are your concerns?
As above.
I believe these processes were put in place when mail was used extensively as a notification method. Technology has moved on and I believe the whole process can be made much simpler and infinitely more efficient.
Why does the TGA need to have ALL customer lists?
I believe these processes were put in place when mail was used extensively as a notification method. Technology has moved on and I believe the whole process can be made much simpler and infinitely more efficient.
Why does the TGA need to have ALL customer lists?
4. Do you have any other suggestions for improving our recall documents?
Do you have any other suggestions for improving our recall documents?
As above
5. Reporting progress with a recall
1. Do you agree with the proposal to remove the initial report (2 weeks) as a requirement under most circumstances?
Please select one item
Radio button:
Ticked
Yes
Radio button:
Unticked
No
Radio button:
Unticked
Not sure
2. Do you agree that a risk-based approach to the reporting requirements would be beneficial?
Do you agree that a risk-based approach to the reporting requirements would be beneficial?
Yes
If not, what are your concerns?
N/A
3. Do you think the questions asked of sponsors in the reports are appropriate?
Do you think the questions asked of sponsors in the reports is appropriate?
Yes
4. Would further guidance on recall reporting requirements and suitable CAPA information be helpful?
Would further guidance on recall reporting requirements and suitable CAPA information be helpful?
No.
CAPA is the responsibility of the sponsor. This detail and any more guidance on reporting could be addressed in training programs on 'How to complete a Recall'
CAPA is the responsibility of the sponsor. This detail and any more guidance on reporting could be addressed in training programs on 'How to complete a Recall'
Confidentiality, publishing submissions and declaration
1. Please advise which parts of your submission you provide consent for us to publish -
Please select one item
(Required)
Radio button:
Unticked
I consent to publishing all of my submission, including my name and organisation details (NOTE: your email address will not be published)
Radio button:
Ticked
I consent to publishing my submission, but without inclusion of my name, email or organisation details
Radio button:
Unticked
I consent to parts of my submission being published, and have indicated the parts which should NOT be published in my submission
Radio button:
Unticked
I do not consent to any of my submission being published
Radio button:
Unticked
I do not consent to my submission being published, but agree to my entity/organisation name being listed as having provided a response
2. Declaration
Please select one item
(Required)
Radio button:
Ticked
Yes