Consultation: Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Lidocaine (lignocaine)

Source: Australian Department of Health

This consultation closes on 18 May 2021.

The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on addition of a proposed new required advisory statement for labels of non-prescription medicines containing more than 1.5 per cent lidocaine (lignocaine) for topical oral use, for inclusion in the Required Advisory Statements for Medicine Labels (RASML) document.

The required advisory statement “Do not use for teething pain in children” is proposed for preparations for topical oral use containing 1.5 per cent or more of lidocaine, to ensure that consumers and health professionals are aware that these medicines are not suitable for use for teething in children.

For more information and to participate in the consultation, please visit consultation hub.

The consultation opens on Tuesday 6 April 2021. Interested parties should respond by close of business, Tuesday 18 May 2021.

Enquiries

Any questions relating to submissions should be emailed to rasml@health.gov.au.

Consultation: Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Sedating antihistamines

Source: Australian Department of Health

This consultation closes on 18 May 2021.

The Therapeutic Goods Administration (TGA) is conducting a public consultation seeking comments from interested parties on changes to current requirements for advisory statements for labels of non-prescription medicines containing antihistamines indicated for short term use in insomnia (diphenhydramine, doxylamine and promethazine), as included in the Required Advisory Statements for Medicine Labels (RASML) document.

For more information and to participate in the consultation, please visit consultation hub.

The consultation opens on Tuesday 6 April 2021. Interested parties should respond by close of business, Tuesday 18 May 2021.

Enquiries

Any questions relating to submissions should be emailed to rasml@health.gov.au.

Consultation: Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Menthol

Source: Australian Department of Health

This consultation closes on 18 May 2021.

The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on the addition of proposed new advisory statements for labels of over the counter (OTC) and registered complementary medicines containing menthol for dermal use, for inclusion in the Required Advisory Statements for Medicine Labels (RASML). The proposal to include advisory statements for menthol in RASML follows previously implemented requirements for advisory statements on labels of menthol-containing listed medicines.

For more information and to participate in the consultation, please visit consultation hub.

The consultation opens on Tuesday 6 April 2021. Interested parties should respond by close of business, Tuesday 18 May 2021.

Enquiries

Any questions relating to submissions should be emailed to rasml@health.gov.au.

Statement by Acting Australian Government Chief Medical Officer, Professor Michael Kidd and Head of the Therapeutic Goods Administration Adjunct Professor John Skerritt

Source: Australian Department of Health

Australia’s vaccine safety and regulatory process is world class and people can be confident that vaccines approved for use are safe and effective. Our vaccines will save lives and are an essential part of tackling this global pandemic.

Australia is taking a phased approach to the vaccination program roll out. Australia is currently utilising two vaccines – the Pfizer and the AstraZeneca vaccines.

Our clear focus during the vaccine rollout remains the safety of all Australians. As throughout the whole of the COVID-19 pandemic, we have relied upon our medical experts for advice and guidance to ensure a safe and effective program delivery.

A small number of people, predominantly overseas (in the United Kingdom and Europe) have presented with clotting disorders following vaccination with the AstraZeneca vaccine.

One case has been reported in Australia today and is being investigated by the Therapeutic Goods Administration (TGA).

Medical experts within the European Medicines Agency and the UK Healthcare Products Regulatory Agency have not confirmed a causal link with the AstraZeneca COVID-19 vaccine but continue to look in great detail at the available data and clinical circumstances around these reports.

Similarly, our expert committees, the Australian Technical Advisory Group on Immunisation (ATAGI) and the National Vaccine Safety Investigation Group (VSIG), in conjunction with our independent regulator, the TGA are monitoring the situation closely, both in Australia and internationally.

ATAGI has released a statement to support health professionals in responding to any instances of clotting disorders following vaccine administration. This provides more information on clinical management and raises awareness of the potential for this condition.

This ATAGI advice was discussed at a meeting of the Australian Health Protection Principal Committee today. ATAGI has reaffirmed the current settings for and safety of the immunisation program.

The TGA will shortly release an updated statement.

Anyone who has received a COVID vaccine should be aware of the common side effects, which include fever, sore muscles, tiredness and headache. These side effects are expected and are not of concern unless severe or persistent.

Both ATAGI and the TGA will continue to monitor the situation closely over the next few days. We remind anyone receiving a vaccination that the reports of possible clotting complications are rare and have occurred in a very small number of cases.

Specific clotting condition reported after COVID-19 vaccination

Source: Australian Therapeutic Goods Administration

Some rare cases of thrombosis associated with thrombocytopenia have been reported overseas following the administration of COVID-19 Vaccine AstraZeneca.

Overnight, the TGA has received one report of a case of thrombosis involving abdominal blood vessels and thrombocytopenia with symptom onset 7 days following COVID-19 Vaccine AstraZeneca in Australia. It is emphasised that that no cause-and-effect relationship between COVID-19 vaccination and this case (or those reported internationally) has been established at this stage.

This case, together with the overseas reports, are under active investigation by the TGA and a panel of external experts (the TGA Vaccine Safety Investigation Group, VSIG). TGA is also working closely with international regulators and is participating in meetings with the UK medicines regulator (MHRA) and the European Medicines Agency to discuss these rare cases over the coming few days.

The TGA is working closely with the Australian Technical Advisory Group on Immunisation (ATAGI) and expert haematologists on the investigation of case reports. ATAGI has today published a statement for healthcare providers (https://health.gov.au/news/atagi-statement-healthcare-providers-specific-clotting-condition-reported-after-covid-19-vaccination; reproduced in full below).

The TGA’s assessment is that the benefits of vaccination against COVID-19 continue to outweigh any risks. More information on the outcomes of investigations into these rare cases will be communicated soon.

Updated ATAGI statement for healthcare providers on a specific clotting condition being reported after COVID-19 vaccination

A statement from the Australian Technical Advisory Group on Immunisation (ATAGI) for healthcare providers on a specific clotting condition being reported after COVID-19 vaccination.

Summary of current recommendations

  • Rare cases of thrombosis associated with thrombocytopenia were reported following administration of COVID-19 Vaccine AstraZeneca overseas.
  • The onset of reported cases was between 4 to 20 days after vaccination.
  • Providers should be aware of warning signs of a severe condition associated with thrombosis and thrombocytopenia. This has presented as either central venous sinus thrombosis (CVST) or thrombosis in other sites, such as intra-abdominal venous systems. CVST may present as a new onset persistent headache not settling with analgesia, features of raised intracranial pressure (including acute severe headache, vomiting, confusion), focal neurological deficits, and/or seizures.
  • If CVST or another severe thrombotic complication with thrombocytopenia is suspected in a patient who has received COVID-19 Vaccine AstraZeneca, refer them to an emergency department for further assessment and haematology consultation.
  • Clinical investigations should include a full blood count (to look for thrombocytopenia), a D-dimer test and radiological imaging.
  • Patients suspected to have this condition should NOT receive any heparin or platelet transfusions.
  • The TGA has received one report of a case of thrombosis and thrombocytopenia following COVID-19 Vaccine AstraZeneca in Australia. The clinical details of this case are currently under review by the TGA.

Vaccination against COVID-19 continues to be important in populations at high risk of COVID.

What is the background to this issue?

There have been reports of rare cases of a distinct type of thrombosis associated with thrombocytopenia following administration of COVID-19 Vaccine AstraZeneca in European countries. The European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) are investigating these reports. The underlying cause of this syndrome has not been confirmed.

Most of these cases involved a type of clot in the brain called cerebral venous sinus thrombosis (CVST). The pattern and mechanism being suggested in these cases resembles a condition called heparin induced thrombocytopenia (HIT), which is caused by antibodies affecting platelet function. In the reported CVST cases, however, there has been no reported exposure to heparin.

This statement is to provide more information and raise awareness of the potential for this condition, plus to provide information on clinical management.

What do we know from investigations into this rare clotting disorder?

The investigations in Europe and the UK are looking at unusual cases of thrombosis (predominantly CVST) with occurs with thrombocytopenia. Investigators have not confirmed a causal link with the AstraZeneca COVID-19 vaccine. However, the investigation is ongoing. CVST is a very rare disorder that has not previously been known to be associated with vaccination, however it has been noted as a complication of COVID-19.

No cases of CVST have been reported in Australia to date in the time period of concern post vaccination (i.e. 4 to 20 days). One case of thrombosis involving a different site with thrombocytopenia with symptom onset in the second week after vaccination has been reported in Australia on 1 April 2021. The details of this case are currently being reviewed by the TGA.

There is not a higher overall rate of relatively common types of blood clots (including deep vein thrombosis [DVT] and pulmonary embolism [PE]) reported after COVID-19 vaccination.

What do we not yet know?

It is also not yet known whether there are any specific risk factors that might predispose an individual to this condition. Many of the cases reported were in adults aged under 55 years, and the majority were in women. However it is not yet clear if age and sex are risk factors, since the AstraZeneca vaccine was preferentially given to younger people in some countries, and since women make up a large proportion of the frontline healthcare workers that were prioritised for vaccination. The European Medicines Agency (EMA) and the UK MHRA intend to provide updated information about their investigation into these cases in early April.

What are the features of this rare condition?

The small number of cases that have been reported to date have been characterised by thrombosis associated with thrombocytopenia. Most reported cases involve cerebral veins (presenting as CVST), but thrombosis of other parts of the body have also been reported. The pathophysiology of this disorder appears to involve platelet activation and thrombosis, resulting in platelet consumption and thrombocytopenia. Anti-platelet antibodies have been reported in a case series. These cases appear to be similar to a disorder known as heparin induced thrombocytopenia (HIT), however, these patients have not reportedly had any history of exposure to heparin.

The symptoms of these rare clotting disorders are distinguishable from common vaccine side effects by time after dose. This is because the onset of these recent cases was between 4 and 20 days after vaccination. Conversely, the common and expected side effects that occur after COVID-19 vaccines have an onset within the first 24 hours and last 1 to 2 days. This includes symptoms such as headache, muscle aches, fever and chills. For more information on the reported pattern of expected adverse events following both AstraZeneca and Pfizer COVID-19 vaccine doses in Australia, see active safety surveillance in Australia for >100,000 vaccinated persons at AusVaxSafety.

What are the warning signs to look out for after vaccination?

Providers should be alert to any new, severe, persistent headache or other significant symptoms, such as severe abdominal pain with an onset between 4 to 20 days after vaccination with COVID-19 Vaccine AstraZeneca. For CVST ‘red flag’ features include new onset of severe persistent headache that is not settling with analgesia. Patients may also present with features of raised intracranial pressure (acute severe headache, vomiting, confusion), focal neurological deficits and/or seizures.

Providers should also consider discussion with a specialist haematologist in any patient presenting with features suggestive of thrombosis in any other body systems, and associated with thrombocytopenia, with onset 4 to 20 days post vaccination. As for all vaccines including COVID-19 vaccines, health care providers should be alert for persistent, unexpected and/or severe adverse events following immunisation in their patients.

What should I do if I suspect a possible case of this clotting disorder?

It is important that clinicians refer patients to hospital for further investigation and specialist consultation, including with a haematologist if they suspect CVST (new, severe persistent headache) or another severe thrombotic complication with thrombocytopenia with an onset 4-20 days post receipt of COVID-19 Vaccine AstraZeneca. Patients should be referred to an emergency department for further investigation and specialist consultation.

Initial investigations should include:

  • Full blood count (to look for thrombocytopenia)
  • D-dimer
  • Fibrinogen
  • Imaging as clinically indicated (for example brain CT or MRI for CVST).

If screening tests suggest HIT-like thromboses (low platelets <100x109/L together with elevated D-dimer 2 x upper limit of normal [ULN] or reduced fibrinogen), a haematologist or haemostasis-thrombosis specialist should be consulted to advise on further investigations (including a HIT screen).

CAUTION: Patients with this suspected condition should NOT receive any heparin or platelet transfusions. These treatments may potentially worsen the clinical course.

In those with a past history of CVST or heparin induced thrombocytopenia (HIT) we continue to advise not receiving the COVID19 vaccine as a precautionary measure, until further information is available.

Further advice can be obtained by phone from the local state and territory specialist immunisation services (or with a haematologist)

ATAGI also encourages health care providers and the public to report any unexpected or serious adverse events occurring following any COVID-19 vaccines.

Community leaders invited to help spread vaccination message

Source: New South Wales Health – State Government

​NSW Chief Health Officer Dr Kerry Chant has reached out to the leaders of culturally and linguistically diverse communities across the state to help spread accurate information on COVID-19 vaccination.
NSW Health and the NSW Multicultural Health Communication Service (MHCS) have been closely working and engaging with multicultural groups throughout the pandemic, providing COVID-19 information in 57 languages.
Dr Chant said community leaders had been invaluable in ensuring information reached everyone, regardless of the language they spoke.
“Over the past year, I’m so grateful that they have helped us by sharing information on subjects like the symptoms of COVID‑19, how to get tested and how to keep COVID safe,” she said.
“Now we are asking them to help us again to make sure everyone gets accurate information they can trust on vaccines and the vaccination process.
“Not all the information circulating out there is correct, so it’s important that people know where to go for the right advice.
“I’m very proud of the work that NSW Health and the NSW Multicultural Health Communication Service have done to ensure that COVID-19 information is accessible to everyone in the community.
“I also want to thank the continuous support of the multicultural health services across the local health districts and state-wide agencies including Multicultural NSW and Service NSW in reaching our communities.”
State Health Emergency Operations Centre Controller Susan Pearce, who is managing the state-wide COVID-19 vaccine rollout, said vaccination would be free for everyone in Australia, including those without Medicare cards.
“We urge everyone who can to be vaccinated when it becomes available to them,” Ms Pearce said.
“Vaccination is one of the key steps to helping us protect our loved ones and being able to resume a more normal life.”
Information on vaccination is available in various languages at https://www.health.gov.au/initiatives-and-programs/covid-19-vaccines/covid-19-vaccine-information-in-your-language

Video interview with Dr Kerry Chant

[embedded content]

Webinar presentation: Special Access Scheme Portal

Source: Australian Department of Health

Disclaimer

This presentation paper is provided on the TGA’s website solely for the purpose of indicating or suggesting what TGA representatives spoke about to the various conferences and seminars to which it relates. The paper is not legislative in nature and should not be taken to be statements of any law or policy in any way.

The Australian Government Department of Health (of which the TGA is a part) advises that (a) the presentation paper should not be relied upon in any way as representing a comprehensive description of regulatory requirements, and (b) cannot guarantee, and assumes no legal liability or responsibility for, the accuracy, currency or completeness of the information contained in the presentation paper.

Presentation

  • Presented by: Petra Bismire
  • Presented at: Online
  • Presentation date: 11 March 2021
  • Presentation summary: Walkthrough changes to the SAS Category B forms and Authorised Application form.

Clinical evidence guidelines: Medical devices

Source: Australian Department of Health

The Clinical Evidence Guidelines for medical devices are intended to provide guidance to manufacturers of medical devices (including In vitro diagnostic medical devices (IVDs)) on what constitutes clinical evidence and the process of clinical data generation and clinical evaluation to produce such clinical evidence. While this guideline refers to IVDs, it is acknowledged that the information provided at this point is incomplete.

Sections of this guidance provide specific information on the clinical evidence requirements for the following types of devices:

  • Total and partial joint prostheses
  • Cardiovascular devices to promote patency or functional flow
  • Implantable pulse generators
  • Heart valve prostheses
  • Supportive devices – meshes, patches and tissue adhesives

There is also a specific section (Section 10) on implantable medical devices in the magnetic resonance environment.

  • Introduction
  • Legislative basis
  • Part 1 – General requirements
    1. The essential principles
    2. Clinical evidence
    3. Clinical evaluation report and supporting documents
    4. Comparable devices including substantially equivalent devices
  • Part 2 – Requirements for specific high risk devices
    1. Total and partial joint prostheses
    2. Cardiovascular devices to promote patency or functional flow
    3. Implantable pulse generator systems
    4. Heart valve replacement using a prosthetic valve
    5. Supportive devices – meshes, patches and tissue adhesives
    6. Implantable devices in the magnetic resonance environment
  • CER and supporting documents
  • Glossary and abbreviations
  • Source material

We aim to provide documents in an accessible format. If you are having problems using a document with your accessibility tools, please contact us for help.

Therapeutic Goods (Medical Devices – Application Form for Priority Applicant Determinations) Approval 2020

Source: Australian Department of Health

I, Meryl Clarke, as delegate of the Secretary of the Department of Health, make the following approval.

Dated 9 December 2020

Meryl Clarke
Assistant Secretary
Medical Devices Authorisation Branch
Health Products Regulation Group
Department of Health

Contents

  1. Name
  2. Commencement
  3. Authority
  4. Definitions
  5. Approved form

1 Name

This instrument is the Therapeutic Goods (Medical Devices—Application Form for Priority Applicant Determinations) Approval 2020.

2 Commencement

  1. Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Commencement information
Column 1 Column 2 Column 3
Provisions Commencement Date/Details
1. The whole of this instrument The day after this instrument is made. 10 December 2020
  1. Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.

3 Authority

This instrument is made under subregulations 4.3B(2) and 5.4A(2) of the Therapeutic Goods (Medical Devices) Regulations 2002.

4 Definitions

In this instrument:

Act means Therapeutic Goods Act 1989.

Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.

5 Approved form

  1. The approved form for an application under subregulation 4.3B(1) of the Regulations for a conformity assessment (priority applicant) determination in relation to a medical device is the form titled Application for priority applicant determination – medical devices published on the Therapeutic Goods Administration’s website.
  2. The approved form for an application under subregulation 5.4A(1) of the Regulations for a medical devices (priority applicant) determination in relation to a medical device is the form titled Application for priority applicant determination – medical devices published on the Therapeutic Goods Administration’s website.

Public health alert – Bluesfest

Source: New South Wales Health – State Government

NSW Health advises that the Minister for Health has signed a public health order cancelling the planned Bluesfest over the Easter period.
This action is being taken to minimise the risk of the highly infectious COVID-19 variant of concern being transmitted in the local area, as well as across states and territories.
Infectious Queensland travellers attended a number of venues in the Byron Bay area and the new locally acquired case was infected at one of these venues.
NSW Health acknowledges that the cancellation of Bluesfest is disappointing for ticket holders and event organisers, however while urgent investigations and contact tracing are ongoing, NSW Health is adopting a cautious approach to keep everyone safe.
NSW Health wishes to acknowledge the outstanding cooperation of Mr Peter Noble and his organising team, who were working hard to ensure Bluesfest would be conducted in a COVID-safe manner.
Minister for Health Brad Hazzard said: “While the cancellation of Bluesfest is disappointing for music lovers and the local community, I hope that ticket holders would support Bluesfest and hold on to their tickets as I understand Bluesfest will be working on a new date as soon as possible.”
As of 5pm today, the following rules will apply to the local government areas of Tweed Shire Council, Ballina Shire Council, Byron Shire Council and Lismore City Council:
Mask wearing will become compulsory on public transport, in retail stores, and in all public indoor settings
the one person per 4 square metre rule will apply at all public indoor settings including hospitality venues
the number of household visitors will be capped at 30 including holiday rental properties.
These restrictions will remain in place until 11:59pm on Monday 5 April, when the community will be updated.
NSW Health urges everyone in NSW, especially in the Tweed, Ballina, Byron and Lismore areas, with even the mildest symptoms, such as headache, fatigue, cough, sore throat or runny nose, to come forward immediately for testing, then isolate until they receive a negative result.
Testing clinics are available at the following Northern NSW locations:
Byron Bay QML Pathology Drive-Through, Cavanbah Sports Ground, 249 Ewingsdale Rd, Byron Bay. Open from 8am to 8pm Monday – Sunday. No referral required.
Byron Bay Walk-in Pop-Up Clinic; Byron Bay surf club, Bay St, Byron Bay. Open from 9am – 5pm. No appointment required.
Lennox Head QML Pathology Drive-through clinic, Lennox Community Centre, Cnr Park Lane and Mackney Lane, 8am – 8pm Monday – Sunday. No GP referral required.
Tweed Heads QML Pathology Drive-through clinic, Cnr Wharf and Florence Street, Tweed Heads, 8am – 8pm Monday -Sunday. No GP referral required.
Lismore QML Pathology Drive – through clinic, 354 Keen Street, Lismore. Open from 8am – 7pm, Monday – Sunday.
There are more than 350 COVID-19 testing locations across NSW, many of which are open seven days a week.
To find your nearest clinic visit COVID-19 testing clinics or contact your GP.