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Medicine shortages/discontinuations - Electronic notification form: User guide

21 December 2018

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Appendix 1

Table column headings explained

The tables below identify the data to be collected within each tab and how it will be used. The column headings are:

  • Field title - how the field is described on the notification form.
  • Explanation - explanation on why this data is required and what it will be used for.
  • Mandatory - is the field required to be completed prior to the notification form being submitted to the TGA. This is further split between information for initial critical notifications only and information for all other notifications.
  • Copied - indicates which fields are duplicated when an existing draft notification is copied to create a new draft notification form.
  • Published - identifies the fields that will be published on the TGA website.
  • Variation - identifies the fields that can be edited when a variation to an existing completed notification is created by a sponsor.

(Pop-up box – for initial notification only)

Field title Explanation Mandatory Copied Published Variation
Critical All others
Impact of shortage As determined by the Sponsor – refer to the Management and communication of medicine shortages in Australia – Guidance for sponsors and other stakeholder bodies. Yes Yes No pop-up box for a copied notification Yes No pop-up box for a variation
Nature of shortage As determined by the Sponsor – refer to the Management and communication of medicine shortages in Australia – Guidance for sponsors and other stakeholder bodies. Yes Yes No pop-up box for a copied notification Yes No pop-up box for a variation
Field title Explanation Mandatory Copied Published Variation
Critical All others
Sponsor Name: This is prepopulated based on the TBS logon ID used. Yes Yes Yes Yes No
Sponsor Address: Select from addresses recorded in TBS for this sponsor. Yes Yes Yes No No
Australian telephone number for public contact purposes: This number will be used by the public if further information is sought. Yes Yes Yes Yes Yes
Medical information email for public contact purposes: This email will be used by the public if further information is sought. Yes Yes Yes No Yes
Primary Contact This will be the point of contact for communications with the TGA – Prepopulated from TBS login. If a different representative from the sponsor is responsible for varying the notification to provide an update these fields will automatically populate with their details.
Name: Prepopulated from TBS login Yes Yes Yes No No
Phone Number: Prepopulated from TBS login Yes Yes Yes No No
Email Address: Prepopulated from TBS login Yes Yes Yes No No
Secondary Contact This will be the point of contact for communications with the TGA if the Primary contact is unavailable.
Name: Chosen from drop-down list No No Yes No Yes
Phone Number: Prepopulated with chosen secondary contact name details No No Yes No Yes
Email Address: Prepopulated with chosen secondary contact name details No No Yes No Yes
Field title Explanation Mandatory Copied Published Variation
Critical All others
ARTG number of the product that has a supply disruption:

Only those ARTG entries that belong with the TBS logon ID can be accessed. A search using the ARTG number returns the following ARTG entry details:

  • ARTG #
  • ARTG name
  • Active ingredient
  • Strength
  • Dosage form
Yes Yes No Yes No
ATC Descriptor: To enable a user of the medicine shortages website to sort by therapeutic class an ATC descriptor needs to accompany the report of the medicine undergoing a shortage. These ATC descriptors are at level 1. No Yes Yes Yes Yes
Are all pack sizes for this ARTG entry affected? Approximately 50% of all ARTG entries have multiple packs sizes listed. As all pack sizes under a single ARTG may not have a supply issue this question is used to distinguish these. No Yes No No Yes
What are the affected pack sizes?

Appears when 'No' radio button is selected for question above.

Please describe the pack sizes that are affected by the shortage here.

No Yes No No Yes
Is this ARTG entry listed in the PBS? If this ARTG entry is listed on the PBS, the Technology Assessment and Access Division will be made aware of the shortage. No Yes No No Yes
Please provide the PBS number for this listing:

Appears when 'Yes' radio button is selected for question above.

The Technology Assessment and Access Division will be made aware of the information

No Yes No No Yes
Do you have the contact details of sponsor's nominated PBS contact?

Appears when 'Yes' radio button is selected for question above.

This person will be the point of contact in your company if the Technology Assessment and Access Division needs to contact your company.

No Yes Yes No Yes
PBS Contact Details

Appears when 'Yes' radio button is selected for question above.

Used if the Technology Assessment and Access Division needs to contact the responsible person in your company.

Name: Appears when 'Yes' radio button is selected for question above. No Yes Yes No Yes
Phone Number: Appears when 'Yes' radio button is selected for question above. No Yes Yes No Yes
Email Address: Appears when 'Yes' radio button is selected for question above. No Yes Yes No Yes
Field title Explanation Mandatory Copied Published Variation
Critical All others
When was the shortage known to the sponsor? This is the date on which the sponsor became aware that there was, or will be, a shortage of the medicine in Australia. This date cannot be a future date. Yes Yes Yes No No
Nature of the shortage: Has the shortage started, ended or yet to begin? Is the product discontinued? This will have prepopulated based on the decision made in the first New Medicine Shortage Notification pop-up screen. This can be changed here but be aware that changes may result in changes to the nature of fields displayed and the number of mandatory fields in the notification. Yes Yes Yes Yes Yes
Shortage reason: Most enquires to the TGA on medicine shortages ask for a reason for the shortage. This is published on the TGA website. Selecting 'Other' brings up a free text box. The free text is not published. Selecting 'Manufacturing' brings up a drop-down list of manufacturing reasons and if other is chosen here there is another free text box to be completed. Only 'Manufacturing' is published as the reason on the TGA website. No Yes Yes Yes Yes

Estimated period supply will be affected at wholesaler points:

From:

The 'From date' is the date from which supply of the medicine is affected. The date entered into this field cannot be a date in the past for an anticipated shortage. For both current and anticipated shortages this date cannot be later than the 'To' date below. Yes Yes Yes Yes Yes

Estimated period supply will be affected at wholesaler points:

To:

The 'To date' is the date by which the period of shortage is estimated to be over. 'To date' field is not displayed if 'Discontinued' is selected as Nature of the shortage. Yes Yes Yes Yes Yes
Availability

For Anticipated shortages and resolved shortages 'available' is prepopulated and cannot be changed. For current shortages and discontinuations a drop-down list of levels of availability are available to best represent the current situation of the product. Sponsors should ensure that this is kept current as this is published on the TGA website.

Definitions of Availability Levels:

  • Available - The product is freely available, there are no constraints or restrictions on supply or availability, no back orders exist
  • Limited availability - The product is available in limited quantities throughout the supply chain. Healthcare professionals may have to place back-orders to obtain the product.
  • Only available under NIP or government programs – FOR VACCINES ONLY – the product is only available for Commonwealth and state/territory vaccination programs and is not available in the private market.
  • Emergency supply only - The product sponsor is actively imposing controls the supply of the product at the current time.
  • Unavailable - The product is not available at this time.
Yes No Yes Yes Yes
Deletion from market date: Appears only if 'Discontinued' is selected as Nature of shortage. This is the date at which there is no stock remaining at the sponsor level. This is NOT the date the product is cancelled from the ARTG. Yes Yes Yes Yes Yes
Do you consent to this notification being published in the interest of public health? Please note that if you choose 'No' the notification may still be published by the TGA under section 61 of the Therapeutic Goods Act 1989. If this were to happen the TGA would notify the sponsor prior to the notification being published. N/A Yes Yes No Yes
Proposed date of publication on the TGA Medicine Shortages website:

This is the date you choose to publish the publishable information within this notification form onto the medicine shortages website.

Note: the actual publication may be delayed by a couple of days if there is a high volume of notifications to be processed.

Yes Yes Yes No Yes
Is this shortage related to other medicines within the same Therapeutic class? Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage. No Yes Yes No Yes
Please enter the details for the other medicines:

Appears when 'Yes' radio button is selected for question above.

Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage.

No Yes Yes No Yes
Is this shortage specific to Australia? Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage. No Yes Yes No Yes
Estimated normal demand volumes for Australia: Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage. No Yes Yes No Yes
Estimated percentage share of the Australian market:

This refers to the share within the market of products containing the actual therapeutic ingredient not the share of the therapeutic class off the ingredient, for example specific vs NSAIDs.

Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage.

No Yes Yes No Yes
Estimated current stock at sponsor / manufacturing level in Australia: Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage. One unit is defined by the sponsor below. No Yes Yes No Yes
Estimated current stock at wholesaler / distributor level in Australia: Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage. One unit is defined by the sponsor below. No Yes Yes No Yes
Please explain what is meant by 1 unit in this context: By defining what you mean by 1 unit you assist the TGA in understanding the exact situation with respect to product quantities available. This assist TGA in understanding the overall situation as different sponsor use different definitions. No Yes Yes No Yes
Field title Explanation Mandatory Copied Published Variation
Critical All others
Are there therapeutic alternatives on the Australian market? Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage. No Yes Yes No Yes
What is the status of substitute options for this product in Australia?

Appears when 'Yes' radio button is selected for question above. Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage.

Definitions of the status:

  • Exact – same medicine (active ingredient, strength and route of administration)
  • Similar – same active ingredient but different strength
  • Appropriate – different active ingredient but same pharmacological class and adverse reaction profiles when administered to patient in therapeutically equivalent doses.

OR

  • Same active ingredient but different dose form that may require consideration of care setting implication
  • Possible – different active ingredient but comparable pharmacological class or mode of action
  • None – unique pharmacology no substitute medicine or alternative treatment options exist
  • Unknown at this time
No Yes Yes No Yes
Are they available in adequate supplies to meet demand?

Appears when 'Yes' radio button is selected for question above.

Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage.

No Yes Yes No Yes
Provide details:

Appears when 'Yes' radio button is selected for question above.

Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage.

No No Yes No Yes
Do any specific population groups use this product?

Examples may be oncology patients, patients with dermatological conditions, paediatric population, etc.

Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage.

Yes Yes Yes No Yes
Provide details of the group and the impact on that group:

Appears when 'Yes' radio button is selected for question above.

Answer will assist the TGA in assessing the extent of the shortage and assist in developing the strategy to manage the shortage.

No Yes Yes No Yes
Based on your answers to the above and your understanding of the Assessment Framework what ranking would you assign to the product experiencing a supply disruption? This will have prepopulated based on the decision made in the first New Medicine Shortage Notification pop-up screen. This can be changed here but be aware that changes may result in changes to the nature of fields displayed and the number of mandatory fields in the notification. Yes Yes Yes Yes Yes
Field title Explanation Mandatory Copied Published Variation
Critical All others
What communication activities have happened or are planned?

Can select up to 5 options that will assist the TGA in coordinating communications and shortage management in parallel with the sponsor. They are letters to:

  • patient advocacy groups
  • pharmacists
  • prescriber
  • subject matter experts, colleges, etc.
  • wholesalers

The date of communication is the date that you intend to send the letter to the group. If the letters are to be sent out in batches, then the date should reflect the first date that the communication is released.

No Yes Yes No Yes
Are you attaching the letter in the supporting information tab? This is a reminder to attach the letter on the following tab. If you answer yes here, the notification will not validate without an attachment being present. It is mandatory to answer this question but not mandatory to attach a letter. Yes Yes Yes No Yes
Further comments on communications: Will assist the TGA in coordinating communications and shortage management in parallel with the sponsor. This is a free text field to communicate information to the Medicine Shortages Section around communications. No No Yes No Yes
What supply management actions have happened or are planned?

Can select up to eight options that will assist the TGA in coordinating communications and shortage management in parallel with the sponsor. They are:

  • Alternate manufacturing changes
  • Apply for 19A
  • Constrained supply
  • No further action product discontinued
  • Working to expedite request to Pharm Chem Section
  • Working to expedite next shipment
  • Importation of Stock for SAS use
  • Supply of substitute medicine approved under section 19A
No Yes Yes No Yes
Further comments on management actions: Will assist the TGA in coordinating communications and shortage management in parallel with the sponsor. This is a free text field to communicate information to the Medicine Shortages Section around sponsor supply management actions. No No Yes No Yes
Field title Explanation Mandatory Copied Published Variation
Critical All others
Supporting data will be: Support information such as a Dear Healthcare Professional Letter can be attached to this notification form or sent to the TGA by other electronic media. If supporting information is to be sent by other electronic media please provide an estimation of the date the support information will be sent to the TGA No No Yes No Yes

Sponsor website:

(ONLY where medicine shortage information is available)

This URL will be a link on the medicine shortages website that will take the user to the sponsor's webpage where the sponsor has provided information relating to the medicine shortage or its management.

Please note: This website will be published IF AND ONLY IF the sponsor website has information relating to the management of the shortage.

No No Yes Yes, but only if the website relates to the management of the medicine shortage Yes

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